Buyer II

R&D/Product Dvl Engineer

Solar Design Engineer

Software Quality Engineer

Staff Electrical Engineer

Senior Software Engineer II

Manager Continuous Improvement

Director, Engineering Services

Manager, Operations

Regulatory Affairs Manager

Responsibilities: <ul><li>Support migration of Indirect Procurement processes from other Global countries to Alabang and prepare Indirect Procurement related process documentation (process maps and work instructions)</li><li>Become a Subject Matter Expert for Indirect Procurement related topics</li><li>Handle and resolve escalated procurement processing issues</li><li>Answer and resolve suppliers, stakeholders and AP queries to ensure timely resolution</li><li>Maintain supplier master data information in relevant systems</li><li>Ensure proper processing of PR’s and PO’s</li><li>Perform compliance checks</li><li>Expedite POs</li><li>Answer tickets (Procurement Helpdesk)</li><li>Manage invoice pricing issues</li><li>Create, maintain Info Record &amp; source lists</li><li>Spot Buy / Requisition Based Sourcing</li><li>Execute all procurement activities in-scope</li><li>Prepare and process eRFQ’s</li><li>Smaller Contract (value/complexity) negotiation &amp; execution</li><li>Execution of Projects assigned by Commodity Management</li><li>Desk Research and Price Comparison</li><li>Supplier training on tools</li><li>End-user Trainings</li><li>Savings reporting</li><li>Maintain communication with suppliers, stakeholders and other Indirect Procurement members</li><li>Execute periodically PR/PO audit queries or upon request KPI’s measurements</li><li>Ensure compliance with applicable client policies</li><li>Contribute to continuous improvement initiatives within the function, ensuring that improvements are incorporated in the work routine</li><li>Support robust compliance environment with applicable policies, procedures and processes</li><li>Build relationship with key stakeholders including suppliers</li><li>Support local BU owners, Function representatives or other Procurement team members to solve issues in a timely manner,</li><li>Build strong relationship with key stakeholders,</li><li>Attend team meetings and trainings as required.</li></ul> Requirements: <ul><li>Good Experience in Indirect Procurement (5+ years)</li><li>Previous experience in shared service environment</li><li>Good of MS office; very good Excel and other relevant tools for the function</li><li>SAP PR2, S/4</li><li>Good communication skills</li><li>Very good English language skills in speech and writing + additional language on top of Filipino preferred (Chinese, Spanish, German, French, etc.)</li><li>Diversified Industrial Products/Manufacturing industry experience preferred</li><li>Good command of other languages is a very important asset</li><li>Experience in a procurement shared service center supporting multiple countries / business units</li><li>Experience working for a Manufacturing company preferred</li><li>Good understanding of end-to-end S2P processes and associated technology platforms</li><li>Excellent organizational and analytical skills, solid problem solving and detail oriented</li><li>Strong communication skills</li><li>Ability to work with deadlines</li><li>Ability to work in culturally diverse teams with many levels of personnel.</li></ul>

Responsibilities: <ul><li>Technical communication to customer, confirm customer application and technical requirement</li><li>Translate customer’s requirement into engineering specification and provide new product design solution in time</li><li>Responsible for part list/BOM building, 3D models and 2D drawings, product specifications, application specifications, DFMEA, DVPR, SC/CC list etc.&nbsp;</li><li>Lead the design review for compliance with engineering principles, high voltage standards, customer contract requirements, verification and related specifications.</li><li>Lead design review with cross functional teams to confirm the manufacturing and quality control feasibility.&nbsp;&nbsp;</li><li>Leads DV/PV test, responsible for resolving product design and test problems.&nbsp;&nbsp;</li><li>Responsible for FAI review, work with project team to release product in time.&nbsp;</li><li>Interacts with customers, vendors, marketing and sales personnel, and other engineering areas during the preproduction stages of new product</li></ul> Requirements:﻿ <ul><li>Education: Bachelor’s degree or above in Mechanical Engineering or equivalent majors.</li><li>3 years of relevant mechanical engineering work experience with electrical components, Motor vehicle connector design.</li><li>Working knowledge in industry standard (USCAR LV214,LV215，USCAR 2.0 ) and related product application</li><li>Knowledge in relevant mechanical design and development, including but not limited to, resin and metal material selection, fundamentals of statics, DFMEA, product qualification, etc.</li><li>Expert in 3D Design Applications (such as Creo, Spaceclaim, etc.)</li><li>Proficient in geometric dimensioning &amp; tolerancing (GD&amp;T). Proficient at limit and fit analysis including statistical tolerance analysis.</li><li>Proficient in developing and writing design objectives for product specifications</li><li>In depth knowledge in manufacturing process (machining, molding, stamping, plating, assembly, etc.) with experience driving Design for Manufacturing (DFM)</li><li>Fluent in English (both verbal and written) to facilitate global communication both internally and with external customers.</li><li>Ability to work in a global environment – able to accommodate varying time zones and capable of collaborating with individuals across geographies.</li><li>Optimistic when facing difficulties and team work spirit</li></ul>

Responsibilities: <ul><li>Work with cross functional teams to transform VOC into internal specifications and design features, documented properly as Product Requirements Document.</li><li>Design and develop new products for renewable applications using metallic and polymeric material to meet customer requirements</li><li>Assess technical risk and compliance of project</li><li>Prototype sample development for feasibility studies</li><li>Product Data management of engineering bill of materials</li><li>Executing on cost optimization/reduction (VA/VE) opportunities for the business</li><li>Engineering communication with global team and localize global product teams in China</li><li>Preparing design verification test plans, Design C Process FMEAs, FEAs</li><li>Engineering sample preparation for design and process verification tests</li><li>Executing test plan within the lab, ensuring successful product testing and verification results</li><li>Perform failure mode analyses and improvements to optimize product</li><li>Recording results of design reviews, design decision meetings, and writing technical summaries</li><li>Assisting with product compliance and approvals for all new products and platforms</li><li>Work with FAI approvals, Process Capability Study, judging manufacturing deviations and make decisions on deviation acceptance</li></ul> Requirements: <ul><li>Must have a minimum of an Bachelors degree in a discipline of Engineering</li><li>More than 5 years design experience on connector, plug or terminal. Solar or battery energy storage relevant or power / utility design experience is plus,not must</li><li>Ability to develop connectors to meet critical global standards, such as ANSI, UL, IEEE, and IEC</li><li>Component material selection to optimize strength, electrical insulation, stability, and longevity, while meeting the product and standard requirements</li><li>Basic knowledge of product development processes in a stage-gate approach</li><li>A basic understanding of manufacturing processes, such as molding, stamping, plating, and assembly processes</li><li>Possesses high degree of initiative, technical competence, engineering process knowledge and strong communication skills</li><li>Fluent communication with own team, customers, internal business leaders and technology leaders in English (CET-4 or above)</li><li>LDFSS or DMAIC 6-sigma black or green belt an advantage</li><li>Familiarity of engineering software: Creo or Pro/E</li><li>Mastery of office software, such as Word, Excel, PPT, etc.</li></ul>

Responsibilities: <ul><li>We develop products in the fields of speech recognition, ambient scribe, and digital dictation. Our products are mainly used in hospitals and medical practices.</li><li>You ensure the quality of our software through automated and manual testing.</li><li>You identify, analyze, and solve simple errors in web applications, iOS, and Android apps.</li><li>You work with E2E testing tools such as Cypress and Detox.</li><li>You collaborate closely with the development team and the Product Owner.</li><li>You support the team with additional testing-related tasks.</li></ul> Requirements: <ul><li>Education in application development or degree in computer science, or several years of experience in test automation (E2E testing) with a focus on web applications or mobile apps.</li><li>Proficiency in TypeScript or another scripting language.</li><li>Strong communication skills with an appreciative style.</li><li>Quick comprehension and independent way of working.</li><li>Strong quality awareness and a passion for testing.</li><li>Very good German skills and good English skills.</li></ul> Other Information: Our Technological Environment: <ul><li>.NET, C#, Web API, Entity Framework, SignalR, WPF, xUnit</li><li>Angular, TypeScript, Electron, Cypress</li><li>React Native, Detox</li><li>Azure DevOps Services with Git</li><li>Microsoft SQL Server</li><li>JetBrains products (Rider)</li><li>Microsoft Windows and Apple macOS as target systems for desktop applications</li><li>iOS and Android as target systems for mobile applications</li><li>Our applications are hosted both in the cloud (Microsoft Azure VMs) and on-premises at our clients’ sites.</li></ul> An Advantage Would Be: <ul><li>Certificate as “Test Automation Engineer” (e.g., ISTQB) or willingness to further your education.</li><li>Experience with CI/CD tools such as Azure DevOps.</li><li>Knowledge of agile methods (especially Scrum).</li><li>Knowledge of database technologies (Microsoft SQL).</li><li>Knowledge of C# and PowerShell.</li></ul> What we offer you (and much more): <ul><li>Alongside a young and modern company culture, you can expect an agile and communicative working environment, great team events, motivating team spirit, and many other benefits:</li><li>A personalized onboarding program so you can fully focus on your new tasks and get to know your new team.</li><li>5 weeks of vacation, increasing to 6 weeks after 3 years, and 7 weeks after 10 years.</li><li>Your birthday off.</li><li>Option to work from home.</li><li>Support and funding for training and further education.</li><li>Free parking, reimbursement of public transport pass, or contribution to your commuting costs, plus a free half-fare travelcard.</li><li>Free coffee, soft drinks, and snacks at the workplace.</li><li>Modern hardware and software, plus a comfortable ergonomic workstation.</li><li>State-of-the-art offices with an in-house game lounge, fitness room, rooftop terrace, and a kitchen with catering options.</li></ul>

Responsibilities: <ul><li>Technical Leadership: Lead multiple advanced technology projects from concept through transfer, ensuring alignment with customer needs, market demands, and industry standards.</li><li>Convert trends into actionable technical roadmap recommendations.</li><li>Innovation &amp; Development: Act as subject-matter expert in cable and interconnect design (analog and digital), including modeling, simulation, and testing.</li><li>Cross-functional Collaboration: Work closely with global engineering and cross-functional teams, managing project budgets, schedules, and deliverables while ensuring strong communication to all stakeholders.</li><li>Documentation &amp; Compliance: Develop and maintain engineering documentation (design specifications, test plans, qualification reports). Ensure compliance with medical device industry standards.</li><li>Mentorship: Mentor and coach junior engineers, providing technical guidance and knowledge transfer.</li></ul> Requirements: Education: <ul><li>Bachelor’s degree in Electrical Engineering (with 8+ years of experience), OR</li><li>Master’s degree in Electrical Engineering (with 6+ years of experience).</li></ul> Experience: <ul><li>Proven experience in electrical interconnect and cable modeling/design/testing.</li><li>Preference for experience in medical device development.</li></ul> Technical Expertise: <ul><li>Proficiency in electrical interconnect modeling, simulation, and signal integrity analysis.</li><li>Hands-on experience with TDR and VNA characterization, high-speed signal testing, and application of transmission line theory.</li><li>Strong experience with full-wave electromagnetic simulations (e.g., Ansys HFSS, Maxwell, SI Wave).</li><li>Data analysis and scripting for test automation.</li><li>Electrical design experience with microcontrollers and embedded systems.</li></ul> Project Leadership: <ul><li>Demonstrated success in leading cross-functional and multi-site technical projects.</li><li>Communication &amp; Collaboration:</li><li>Excellent written and verbal communication skills.</li><li>Ability to collaborate effectively across multiple geographies.</li></ul> Personal Attributes: <ul><li>Self-motivated, adaptable, quick learner, and able to work independently while contributing to team success.</li></ul> Preferred Qualifications <ul><li>Familiarity with catheter-based medical devices and their regulatory standards.</li><li>Knowledge of EMI/RFI characterization for cables and connectors.</li></ul>

Role Description: <ul><li>Mexico City Are you ready to translate complex product needs into innovative software designs? How would you like to leverage your expertise in resolving technical issues and mentoring less-senior developers? About our Team We serve customers in more than 150 countries with 11,800 employees worldwide, a global provider of information-based analytics and decision tools for professional and business customers.</li><li>Our company has been a long-time leader in deploying AI and advanced technologies to the legal market to improve productivity and transform the overall business and practice of law, deploying ethical and powerful generative AI solutions with a flexible, multi-model approach that prioritizes using the best model from today’s top model creators for each individual legal use case.&nbsp;</li><li>About the Role This position performs complex research, design, and software development assignments within a software functional area or product line, and provides direct input to project plans, schedules, and methodology in the development of cross-functional software products.&nbsp;</li><li>This position performs software design — typically across multiple systems; mentors more-junior members of the team; and talks to users/customers and translates their requests into solutions.&nbsp;</li></ul> Responsibilities: <ul><li>Collaborate with technical team members to refine and finalize software requirements.</li><li>Contribute to the design and development of complex system components.</li><li>Identify and resolve software issues and bugs.</li><li>Translate product requirements into effective software solutions.&nbsp;</li><li>Apply and promote best practices in coding, development processes, and code reviews.</li><li>Work in various development environments (e.g., Agile, Waterfall) with cross-functional teams.&nbsp;</li><li>Stay current with emerging technologies and industry trends.</li><li>Design and manage complex data models.&nbsp;</li><li>Support and mentor junior team members in development techniques and methodologies.</li><li>Share knowledge and contribute to a culture of continuous learning and improvement.&nbsp;</li></ul> Meal/Grocery Voucher Responsibilities&nbsp; <ul><li>Collaborate with technical team members to refine and finalize software requirements.</li><li>Contribute to the design and development of complex system components.</li><li>Identify and resolve software issues and bugs.&nbsp;</li><li>Translate product requirements into effective software solutions.</li><li>Apply and promote best practices in coding, development processes, and code reviews.</li><li>Work in various development environments (e.g., Agile, Waterfall) with cross-functional teams.</li><li>Stay current with emerging technologies and industry trends.&nbsp;</li><li>Design and manage complex data models.&nbsp;</li><li>Support and mentor junior team members in development techniques and methodologies.&nbsp;</li><li>Share knowledge and contribute to a culture of continuous learning and improvement.</li></ul> Requirements: <ul><li>5+ years of experience in software development or a related field.&nbsp;</li><li>Degree in Computer Science, Engineering, or equivalent practical experience.</li><li>Based in or near Mexico City, with the ability to work onsite 2 days per week (Glorieta del Ahuehuete, Reforma).</li><li>Proficiency in .NET (C#).</li><li>Strong skills in data manipulation and optimization techniques.</li><li>Solid understanding of data modeling (normalized and dimensional).</li><li>Familiarity with test-driven development and modern development tools.</li><li>Effective communication skills, both written and verbal.</li><li>Ability to collaborate with diverse teams and stakeholders.</li><li>Commitment to inclusive, accessible, and high-quality software development.</li></ul> Other Information: <ul><li>Work in a way that works for you We promote a healthy work/life balance across the organization.</li><li>We offer an appealing working prospect for our people.</li><li>With numerous wellbeing initiatives, shared parental leave, study assistance and sabbaticals, we will help you meet your immediate.&nbsp;</li><li>Working flexible hours - flexing the times when you work in the day to help you fit everything in and work when you are the most productive.</li><li>Working for you We know that your well-being and happiness are key to a long and successful career.</li><li>These are some of the benefits we are delighted to offer:</li><li>Private Medical/Dental Plan</li><li>Savings Fund</li><li>Life Insurance</li></ul>

Responsibilities: <ul><li>Implement and champion company OA principles (company Continuous Improvement System) and tools across Operational and Supply Chain Planning processes.</li><li>Identify areas for improvement and lead projects to enhance operational efficiency and effectiveness.</li><li>Collaborate with cross-functional teams to develop and implement best practices in operational and supply chain planning.</li><li>Conduct process mapping, root cause analysis, and develop innovative solutions to complex problems.</li><li>Provide coaching on LEAN activities and Lead Kaizen events and other continuous improvement initiatives within the operational and supply chain planning domain.</li><li>Develop and track key performance indicators (KPIs) to measure the success of LEAN initiatives.</li><li>Provide training and mentoring to team members on company OA methodologies and tools.</li><li>Create and maintain documentation of best practices and standard operating procedures.</li><li>Regularly report on project progress and outcomes to senior management.</li></ul> Requirements:﻿﻿ <ul><li>Bachelors degree in Supply Chain Management, Business Administration, Industrial Engineering, or a related field</li><li>5+ years of experience manufacturing added advantage form Semicon, medical line, EE manufacturing, automation or operations management.</li><li>3 years people manager skill are desirable.&nbsp;</li><li>Good engagement, communication, and hands on skills on handling of Continuous Improvement principles and their application in operational and supply chain processes.</li><li>Proven track record in implementing continuous improvement methodologies (e.g., Lean, Six Sigma).</li></ul>

Role Description: <ul><li>The Director, Engineering Services leads engineers and maintenance staff to maintain the existing facilities and equipment while developing engineering solutions to operational issues or new processes.</li><li>This position implements capital projects, establishes engineering project objectives and technical criteria for evaluating project results and activities of project team while supporting the policies, goals and objectives of the Company.</li></ul> Responsibilities: Engineering Project Management and Qualification <ul><li>Member of Site Leadership Team</li><li>Develops, plans, coordinates and directs engineering aspects of projects of major scope and importance</li><li>Manages IQ, OQ, PQ program. ?	Manages external engineering services and recommends resources required to carry out projects or improvements</li><li>Routinely has direct contact with outside consultants, technical counterparts from key vendors</li></ul> Facilities and Equipment Maintenance&nbsp; <ul><li>Directs the maintenance staff for routine PM and unplanned repairs of facilities and production equipment.</li><li>Manages calibrations within the plant through in-house or contract services.</li><li>Supports Serialization within the plant.</li></ul> Cross Functional Coordination&nbsp; <ul><li>Supports safety, health, and environmental policies and procedures</li><li>Works with Environmental Health and Safety to ensure city, county, state, and federal regulations relating to the projects and process improvements are met at all times</li><li>Directs, and enforces the safety program for the engineering group and reviews safety records to uphold standards of maximum safety for all maintenance and calibration staff</li><li>Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments</li><li>Communicates directly with the operations departments to coordinate engineering activities</li><li>Communicates directly with QA and QC laboratory to ensure effective participation by engineering staff in the implementation of QA policies and procedures</li></ul> Plant/Process Improvement&nbsp; <ul><li>Communicates regularly with all engineers, both individually and as a group, to ensure good two-way communication concerning operational improvements and projects</li><li>Assists with planning and implementing plant improvements and expansions</li><li>Prepares reports, analyzes data, and makes recommendations for improving plant operations and solving manufacturing/packaging-related problems</li><li>Initiates and carries out projects that improve efficiency and/or reduce operating costs</li><li>Coordinates with maintenance and operations staff in reviewing the operation of plant equipment and systems to minimize unplanned downtime, anticipate solve problems in a timely manner, and to identify opportunities for improvement</li></ul> Supervisory Responsibilities&nbsp; <ul><li>Conducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution of the engineering staff</li><li>Ensures that all engineering staff are trained on the most updated version of the operating procedures</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor of Science in a related technical field plus progressive technical experience and demonstrated competence</li><li>10 years progressive management experience in pharmaceutical engineering, pharmaceutical operations, and operations management</li></ul> Knowledge In-depth knowledge of the pharmaceutical plant operations is an asset Skills &amp; Abilities <ul><li>Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates activities; Makes oneself available to staff; Provides regular performance feedback; Develops subordinates skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.</li><li>Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.</li><li>Analytical -Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.</li><li>Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.</li></ul> Physical Requirements <ul><li>Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds</li><li>Climb ladders and work in high, precarious places up to elevations of 75 feet</li><li>Regularly exposed to work near moving mechanical parts</li><li>Exposed to wet or humid conditions</li><li>Exposed to outdoor weather conditions</li><li>Regularly exposed to high noise environments</li><li>Exposed to extremely dusty environments</li><li>Exposed to chemicals used in the manufacturing process Engineering</li></ul>

Role Description:&nbsp; <ul><li>The purpose of this job is to oversee the production schedules in accordance with approved production instructions, standard operating procedures, while utilizing cGMP for the preparation of commercial product.</li><li>Monitor and document in a periodic performance review the performance of the production staff. Identify opportunities for process and equipment improvements.</li><li>Mentor staff and set goals and objectives for the production personnel.</li></ul> Responsibilities: <ul><li>Manufacturing Operations Management</li><li>Assure the accurate execution of cGMP/DEA documentation relative to manufacturing and packaging activities.</li><li>Assure the accurate manufacturing of bulk drug product for delivery to primary packaging without deviation.</li><li>Assure the accurate packaging of drug product in approved primary packaging components without deviation</li><li>Assure the accurate sampling of raw material and the packaging of samples for shipment as appropriate to contract testing laboratories.</li><li>Assure the accurate assessment of component inventory and reconciliation.</li><li>Assure staff training requirements are established and complete prior to the performance of process or procedure.</li><li>Assure the accurate performance of basic routine preventive maintenance of equipment and facility cleaning activities by operators.</li><li>Establish performance Goals and Objectives based on facility needs and High Corporate Standards.</li><li>Complete routine performance evaluations of staff, and recommend growth opportunities.</li><li>Assure adherence to established production schedules and monitor production performance as determined by the Plant Director.</li><li>Monitor the general safety of staff and assure safe work practices are followed by all site personnel.</li></ul> Requirements: Education &amp; Experience <ul><li>Undergraduate Degree in Pharmacy, Engineering, or equivalent in training and experience.</li><li>10 years’ experience in a pharmaceutical manufacturing environment.</li><li>Prior cGMP experience in a pharmaceutical production environment is necessary. 3-5 years’ previous supervisory experience required.</li><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li></ul> Knowledge&nbsp; <ul><li>Knowledge of workplace health and safety requirements for applicable hazardous substances.</li><li>Must be able to demonstrate a high degree of understanding in the cGMP practices.</li><li>Must be able to demonstrate a high degree of understanding in the controlled drug substance regulations.</li><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li></ul> Skills &amp; Abilities <ul><li>Demonstrate knowledge of the current good manufacturing practices.</li><li>Ability to convey information clearly and concisely to both individuals and groups.</li><li>Ability to troubleshoot manufacturing processes, write investigations and complete documentation.</li><li>Ensure adequate staffing and efficient workflow and provide reports and data on manufacturing activity.</li></ul> Physical Requirements	 <ul><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary. Able to walk the production floor.</li><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary.</li><li>Able to walk the production floor.</li></ul>

Responsibilities: <ul><li>Ensure all products comply with applicable laws, regulations, and standards as per Indian laws</li><li>Stay updated on regulatory changes and assess their impact on the companys products or processes.</li><li>Either prepare or coordinate with originator, review, and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing.</li><li>To do necessary follow-ups with regulatory agencies to get approval of the medical devices / pharmaceutical products.</li><li>Work with Originator, and marketing teams to ensure product alignment with regulatory requirements.</li><li>Lead or assist in regulatory audits conducted by agencies or certification bodies.</li><li>Identify and mitigate regulatory risks that could impact product approvals or market access.</li><li>Develop and implement regulatory strategies to accelerate market entry and ensure sustained compliance.</li><li>Conduct training sessions for cross-functional teams on regulatory requirements and best practices.</li></ul> Requirements: Skills and Qualifications: <ul><li>Bachelors degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering.</li><li>Advanced degree (e.g., MBA, MS, or Ph.D.) is an advantage</li><li>Strong knowledge of regulatory requirements (CDSCO, FDA, EMA, MHRA, TGA, etc.) and global standards (ISO, ICH, etc.)</li><li>Excellent project management and organizational skills</li><li>Ability to analyze and interpret complex regulations</li><li>Proficient in regulatory writing and submission tools</li><li>Strong communication and interpersonal skills</li><li>Ability to manage multiple projects and meet deadlines.</li></ul> Experience : <ul><li>7-10 years of experience in regulatory affairs, with a proven track record of successful submissions and approvals</li><li>Experience in handling registration of Medical Devices and getting approval.</li></ul>

Skills

Industry

Location

Jobtitle

38 medical writing Jobs found

Buyer II

R&D/Product Dvl Engineer

Solar Design Engineer

Software Quality Engineer

Staff Electrical Engineer

Senior Software Engineer II

Manager Continuous Improvement

Director, Engineering Services

Manager, Operations

Regulatory Affairs Manager

WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

38 medical writing Jobs found

Buyer II

R&D/Product Dvl Engineer

Solar Design Engineer

Software Quality Engineer

Staff Electrical Engineer

Senior Software Engineer II

Manager Continuous Improvement

Director, Engineering Services

Manager, Operations

Regulatory Affairs Manager

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.