Regulatory Affairs Manager

Supply Chain Analyst

Laboratory Supervisor

125112 Assembly Vision System Engineer

127202 / 127203 Certified Quality Engineer

118175 Molding Manufacturing & Process Development Engineer

Lead Medical Affairs

Quality Engineer IV

Bi-Lingual HR Generalist

Business Development Manager – Partner Business

Job Summary: <ul><li>The Regulatory Affairs Manager is responsible for ensuring that the companys products meet all regulatory requirements and standards in the markets where they are sold. This role involves managing the regulatory approval process, keeping up to date with regulatory changes, and ensuring compliance with all relevant laws and guidelines.&nbsp;</li><li>The Regulatory Affairs Manager will also collaborate with cross-functional teams to provide guidance on regulatory issues and strategies.</li></ul> Responsibilities: Regulatory Compliance and Strategy: <ul><li>Lead and manage regulatory submissions and ensure compliance with local regulations.</li><li>Develop regulatory strategies for the approval and commercialization of products or product changes.</li><li>Keep abreast of changing regulations and ensure the company remains in compliance with evolving regulatory environments.</li></ul> Product Registration and Documentation: <ul><li>Prepare, review, and submit regulatory documents, including product dossiers, to relevant regulatory agencies.</li><li>Coordinate with internal teams to ensure that all necessary documentation for regulatory submissions is accurate and complete.</li><li>Maintain regulatory files and ensure they are up to date and readily accessible.</li></ul> Cross-functional Collaboration: <ul><li>Work closely with marketing teams to provide regulatory input and ensure compliance is integrated into the planning.</li><li>Provide regulatory guidance and support to cross-functional teams, ensuring the timely and successful approval of products or product changes.</li><li>Assist in the preparation of marketing materials and labeling to ensure compliance with regulatory requirements.</li></ul> Regulatory Approval Process: <ul><li>Manage the regulatory approval process for products, product changes, and renewals, ensuring timely approvals in target markets.</li><li>Communicate with regulatory agencies as needed to clarify issues, respond to inquiries, or resolve regulatory concerns.</li></ul> Risk Assessment and Compliance Monitoring: <ul><li>Identify regulatory risks related to marketing, or distribution, and recommend mitigation strategies.</li><li>Monitor product performance post-market to ensure continued compliance with regulatory requirements.</li><li>Review and assess the impact of new or revised regulations on current and future products.</li></ul> Regulatory Affairs Training: <ul><li>Educate and train internal teams on regulatory affairs and compliance requirements.</li><li>Conduct workshops or presentations to ensure team members are aware of regulatory standards and best practices.</li></ul> Regulatory Reporting and Documentation: <ul><li>Maintain and track regulatory submissions and approvals, preparing status reports for senior management.</li><li>Prepare regulatory updates and reports for regulatory authorities, as needed.</li></ul> Audit and Inspection Support: <ul><li>Support internal and external audits related to regulatory compliance.</li><li>Participate in regulatory inspections or audits and manage the documentation and communication during such events.</li></ul> Requirements: Education:&nbsp; <ul><li>Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or a related field.</li></ul> Experience:&nbsp; <ul><li>5+ years of experience in regulatory affairs, preferably in the relevant industry (e.g., pharmaceuticals, medical devices, direct-to-consumer).</li></ul> Knowledge:&nbsp; <ul><li>In-depth knowledge of local regulatory requirements and regulatory submission processes.</li></ul> Skills: <ul><li>Strong communication, organizational, and project management skills.</li><li>Ability to interpret and apply regulatory guidelines and laws.</li><li>Excellent attention to detail and ability to manage multiple priorities.</li><li>Experience with regulatory submission software and tools.</li><li>Ability to work cross-functionally with different departments and stakeholders.</li></ul>

Responsibilities: <ul><li>Recommend and Deploy System Solutions to improve Supply Chain Systems and resolve process issues</li><li>Conduct Business Process Reviews, identifying SAP Business Process Gaps and Deploying Best Demonstrated SAP Business Processes, maintaining consistency across SENSORS sites</li><li>Improve SAP proficiency and process knowledge across SENSORS Supply Chain Organization</li><li>Create and Maintain Training Material and Knowledge Content</li><li>Develop and Train all Supply Chain Key User Community</li><li>Develop Business Requirements Documents and Identify ROI for Systems Enhancements</li><li>Perform User Acceptance Testing and Deployment of Latest SAP Enhancements</li><li>Promote, Maintain, Enforce Master Data Integrity and Governance.</li><li>Troubleshoot, Identify, and Resolve SAP Issues as liaison to the whole Supply Chain Organization and company Information Systems.</li></ul> Requirements:&nbsp; <ul><li>Bachelor’s degree in Supply Chain, Industrial Engineering, Information Systems or similar&nbsp;</li><li>Working knowledge of Supply Chain processes, Materials Resource Planning Systems, Engineering Master Data including BOMs, Routes, Material Masters, Info Records, Source Lists.</li><li>Minimum of 5 years experience in Supply Chain/Logistics, Procurement or Industrial Engineering, including detailed knowledge of SAP processes and capabilities within SAP PUR/MM/MDG/ modules</li><li>Training expertise for both classroom and one on one training situations</li><li>Excellent project manager with very good organizational capabilities</li><li>Solid influencing skills, particularly where there is no reporting relationship</li><li>Problem/root cause identification and communication skills</li><li>Excellent team building skills and ability to motivate and persuade associates from the plant floor level through management. “Getting things done through other people”</li><li>Ability to translate Business needs into company IS Business Requirements Documents</li><li>Ability to effectively conduct requirements gathering sessions and concisely documenting the outcome&nbsp;</li><li>Travel domestically &amp; internationally as needed (10-20%)</li></ul>

Responsibilities: <ul><li>Collaborates with engineering, operations and customers to plan and test products.</li><li>Facilitates development processes, coordinates materials and component integration.</li><li>Execution and evaluation of tests.</li><li>Support of the laboratory team with special technical problem solving.</li><li>Scheduling and allocation of tests to be carried out.</li><li>Equipment utilization optimization</li><li>Clarification of the test conditions and the creation of the specifications for the test</li><li>Continuous improvement process,EHS</li><li>Disciplinary and methodical leading of the team Creates and monitors development plans; communicates working activities/status to team, management, sales and operations.</li><li>Supervises and supports development staff; participates in training, development and performance management of team members, as well as conducting annual employee evaluations.</li></ul> Requirements: <ul><li>Bachelor’s degree in electrical engineering is a must. Master’s degree is a plus.</li><li>Minimum of 2 years of experience in a supervising role in a test laboratory related to electrical testing.</li><li>MS Office.</li><li>Automation knowledge is an advantage.</li><li>Electrical schematic basics are an advantage.</li><li>CAD basics are an advantage.</li><li>Knowedgle of the system LIMS (Laboratory Information Managment System) is an advantage.</li><li>Electronic design and PCB routing is an advantage.</li><li>English fluent and fluent in Czech.</li></ul>

Responsibilities: Quality Documents Preparation and Revise: <ul><li>DQIP Workmanship Control Plan.</li><li>Identify the key process basing on quality control and assure process quality.</li><li>Prepare DQIP, workmanship and Control Plan, and quality control document according to procedure.</li><li>Setup &amp; FAAR。</li><li>Basing on product, Process and procedure, review and approve Setup and FAAR report.</li><li>MSA (GRR) gage</li><li>Do assessment on product and measurement tool, prepare MSA (GRR) report. Calibrate the inspection equipment as gage and process inspection machine to assure the efficiency.</li><li>PFMEA，</li><li>Assure the process risk control basing on efficient PFMEA.</li><li>NCR &amp; QA instruction&nbsp;</li><li>NCR&amp; QA instruction prepare and confirmation, assure the good control on non-confirming parts.</li></ul> Customer Quality: <ul><li>Fast response for customer complaints to drive customer satisfaction</li><li>Drive internal improvement and expansion based on customer complaints</li><li>8D TECHS - 8D report prepare and TECHS system handling.</li></ul> Process Improvement: <ul><li>In association with engineering department and production department to identify and analyze problems of production process, find out the root cause of failures</li><li>Do process capability analysis and defect statistic analysis, to increasing the product &amp; process quality</li><li>NPI product and process study to assure the NPI goes well on quality control.</li><li>Engage process improvement, confirm implementing and tracking effects and results</li></ul> Training: <ul><li>providing practical training to QC and operators</li><li>Quality Improvement Summary and Sharing</li></ul> Requirements: Education, Technical Qualification &amp; Experience: <ul><li>Bachelor degree in technical or related major.&nbsp;</li><li>Minimum 1 year working experience in Quality management， connector working experience preferred.</li><li>English can be working language</li><li>MSA、SPC、FACA</li><li>Familiar with quality management tools, such as MSA, SPC, FACA etc</li></ul>

Responsibilities: Customer Quality Complaint Handling: <ul><li>Customer complaint initial check, on site investigation, CSR quick check &amp;support, strong driving ability to deliver solution for customer</li><li>Quick initial response or containment actions for customer</li><li>Publish complaint to company manufacturing plant and timely follow up</li><li>Internal 5D/8D driving / evaluation / on time deliver to customer</li><li>External 8D release and report to customer</li><li>Timely progress tracking, update and in time escalation</li><li>D6/LL/RA/CTP verification to make sure 8D effective closure&nbsp;</li></ul> Capability in Application &amp; Engineering:&nbsp; <ul><li>Good understanding of OEM production line assembly process</li><li>Strong problem solving ability &amp; tools capability like FTA, DOE...</li><li>Engineering basics such as GD&amp;T, good product &amp; application knowledges.</li><li>Sensitiveness to study/bench marking solutions from other competitors</li></ul> General quality topics coordination (internal &amp; external): <ul><li>Green scorecard driving with responsible key customers</li><li>Take leader as the pliot CQ leader for Chery, responsible for continues quality improvement coordination and regular meeting &amp; communication with various customer SQM interfaces.</li><li>Customer visit, CTP identify, proactive customer reporting &amp; quality workshop…coordination &amp;lead</li><li>Coordinate Training/Meeting/Audit/Quality documents...requested by customer&nbsp;</li><li>Manage the on site service people in Chery Wuhu, to deliver excellent service to customer</li></ul> Quality Data Analysis and Reporting: <ul><li>Maintain customer quality data in system/worksheet, timely tracking &amp; monitor.</li><li>Data analysis and reporting, performance tracking, improvement opportunity identify and driving.</li></ul> Requirements: <ul><li>Full-time degree or diploma holder</li><li>Minimum 3 years of customer quality experience </li><li>Previous exposure from automotive industry is preferred</li></ul>

Responsibilities: <ul><li>Has strong impact in Advanced Manufacturing Technology Roadmap driven development projects.</li><li>Drives for excellence in existing Stamping technologies and methods.</li><li>Strives to implement optimized or new manufacturing technologies to provide improved processes and tolerance control.</li><li>Act as a liaison between the Advance Manufacturing Process team and the manufacturing sites teams to collaborate with Product Development in the optimization of part and product designs for manufacturability, providing stamping simulation and process master knowledge and expert application of stamping processes to realize product samples and prototypes.</li><li>Provides stamping simulation and process master knowledge and project management to liaise the Advance Manufacturing Process team and the manufacturing sites teams, deploying optimized or new stamping processes to realize advanced manufacturing technology development projects.</li><li>Acts as the binding element between product development and advanced manufacturing &amp; process engineering, ensuring the effectiveness and efficiency of this critical interface.</li><li>Designs, develops, and qualifies stamping processes in compliance with company EH&amp;S, quality and production standards, as well as recognized best in class and industry standards.</li><li>Documents all related processes in applicable company systems.</li><li>Supports supply chain to verify related suppliers’ compliance and capability.</li><li>Initiates and implements stamping related programs to continuously improve quality, cost and cycle time.</li><li>Maintains and adheres to all appropriate specifications, regulatory and customer requirements.</li><li>Applies stamping process mastery to resolve significant / unique / complex issues, where analysis of situations or data requires an in-depth evaluation of variable factors.</li><li>Exercises considerable latitude in determining objectives and approaches to assignment, performing work without appreciable direction.</li><li>Drives results primarily through collaboration and influence, not through direct reporting relationships.</li><li>Provides training and mentorship to other professional employees.</li><li>Provides measurable input to the objectives and goals of the department in support of the function and business unit strategies.</li></ul> Requirements: <ul><li>Minimum 12 years of related experience.</li><li>Bachelor’s Degree (Mechanical Engineering or related) required, Master’s preferred.</li><li>Demonstrates stamping simulation and process mastery (tool design, process optimization, capability, troubleshooting).</li><li>Tight tolerance electrical connector experience is a plus!</li><li>Working knowledge with quality tools (FMEA, Six Sigma, DOE, 8D/Continuous Improvement), is a plus!</li><li>Fluent in English (read, write, and speak).</li><li>Broad knowledge of stamping, plating, and assembly processes for connectors and sockets is desired.</li><li>Practical application of MS Office software (Word, Excel, PPT, Project, &amp; Outlook).&nbsp;</li><li>Broad project management skill and experience – Ability to work on several projects at once.</li><li>Based in China-Qingdao or the Philippines-Batangas mfg. sites and willingness to travel up to 25% average.</li></ul>

Responsibilities: <ul><li>To effectively lead the Medical Affairs activities for segment across therapy areas, providing effective business enablement and high edge scientific activities towards achieving disease and therapy area leadership and enhancing access of products in disease and therapy areas of interest.</li><li>Build connect with KOLs in shaping Therapy understanding and molecule understanding. CME/Ad board conduct, support guidelines, consensus etc.</li><li>Help in evaluation of New Products for therapy prominence working portfolio and strategy team and marketing team.</li><li>To have scientific activities those are considered differentiated and purposeful for targeted audience.</li><li>Guide marketing teams in ensuring proper medical inputs and activities are delivered as per compliance.</li><li>Identifying need and planning evidence generation and post marketing studies.</li><li>Support Medical writing , Publication and communication.</li></ul> Activities for Digital Platforms &amp; Other activities: <ul><li>Compliance in medico marketing activity.</li><li>Evidence generation activities.</li><li>Evaluation of New Products.</li><li>Medico-marketing Support.</li><li>Training and Development.</li><li>Scientific Updates.</li></ul> Requirements: <ul><li>MD (Pharmacology/Medicine) / MBBS.</li><li>5-8 years of experience in Medical Affairs.</li><li>Freshers with exceptional academic qualifications will be considered.</li></ul> Skills: <ul><li>MS Office.</li><li>Business Acumen.</li><li>Disease/Therapy Knowledge.</li><li>Broad Understanding of Medical Affairs.</li><li>Excellent Relationship Building Skills.</li><li>Excellent written &amp; oral communication skills.</li><li>Confidence to interact with Internal &amp; External Stakeholders.</li></ul>

Responsibilities: <ul><li>Function as the voice of the customer regarding quality issues and to represent Laird to the customer.</li><li>Develop working relationships with assigned customers and team members.</li><li>Develop, revise, and maintain Quality documentation as necessary.</li><li>Facilitate and participate in the Continuous Improvement efforts utilizing Quality Tools.</li><li>Facilitate and participate in the Corrective Action process (8D), the MRB (Material Review Board) process, the First Article process, Part Certification process, and the Business System Auditing process.</li><li>Oversee and direct the activities of Quality Inspectors as assigned to achieve quality objectives.</li><li>Monitor partners and suppliers regarding effective and on time failure analysis; review their 8D-reports.</li><li>Advise in Advanced Quality Planning for New Products as required by Project Management</li><li>Advise Departments with Quality System and Product Quality related issues and coordinate the Quality effort.</li><li>Supervise failure analysis of components returned by the customer as required.</li><li>Create quality related reports for internal and external distribution.</li><li>Perform supplier audits, internal audits and participate in customer audits.</li><li>Establish and maintain quality data like PPM, D/P-FMEA, 8Ds, PPAPs, SPC, MSA and others as appropriate.</li><li>Work with manufacturing partners and suppliers regarding their specific requirements.</li><li>Coordinate the PPAP process (including developing, reviewing and approving FMEAs, Control Plans, MSA, SPC, etc. as appropriate) working with all parties involved (e.g., engineering, suppliers/manufacturing partners, operations…) to ensure customer and Laird.</li><li>Provide training on quality related topics to others in the organization.</li><li>Adheres to quality and safety systems or maintenance of quality and safety standards.</li></ul> Requirements: <ul><li>Excellent communication skills</li><li>Effectively present information and respond to questions from groups</li><li>Ability to work with management to establish and execute project milestones.</li><li>Ability to work toward defined objectives, targets, and goals with minimal supervision.</li><li>Demonstrated strength of new product development processes and work flow.</li><li>Works well in a team environment and guides the team as the “expert” in a particular field.</li><li>Demonstrated experience in participating on multi-disciplinary product development teams</li><li>Good knowledge of a particular technical area within the job responsibility.</li><li>Able to work successfully in a deadline-driven, fast paced environment and effectively multi-task multiple priorities in a team-oriented environment.</li><li>Must be flexible and able to adapt to changing requirements and schedules</li><li>Knowledge and experience with TS16949 and ISO9001: 2000.</li><li>Ability to read interprets and analyzes blueprints.</li><li>Advanced Flowcharting ability and procedure analysis.</li><li>Advanced knowledge of statistical process control.</li><li>Ability to use precision measuring instruments.</li><li>Bachelors Degree in Engineering or related field, Masters Degree preferred.</li><li>8 or more years of experience</li></ul>

Responsibilities: <ul><li>Incorporate best practices in developing, implementing, and executing processes related to recruiting, onboarding, policy administration, employee relations, performance management, payroll and benefits administration, employee development, and regulatory compliance, primarily for the Operations division.</li><li>Support performance management life cycle to include goal setting, mid-year, and annual performance reviews.</li><li>Consult with employees and plant leadership to raise and resolve minor workplace issues. Regularly assess the plant climate and employee engagement.</li><li>Make recommendations to improve and ensure a vibrant culture and good work environment.</li><li>Administrative HR duties include answering general employee questions, maintaining employee files, data entry, managing job descriptions, unemployment claims, employment verifications, and creating KPI dashboards/reports.</li><li>Respond to employee HR-related questions regarding benefits, paychecks, leave of absence, PTO, etc.&nbsp;</li><li>Coordinate onboarding for new employees, including temporary plant employees.</li><li>Create and conduct HR-related presentations such as supervisor training, Code of Conduct training, goal setting, and new hire orientation.</li><li>Led the Leave Administrative Process for our client regarding FMLA, Worker’s Comp, Personal leaves, military leaves, STD, and LTD; initiated leave cases and serve as a liaison between the company, employee, and our third-party leave administrator.</li><li>Assists with recruiting functions such as scheduling interviews, reviewing job openings, and reviewing resumes with hiring managers.</li><li>Reviews, maintains, and inputs employee data into UKG and runs regular reports to validate data entered into the system.</li></ul> Requirements: <ul><li>Minimum of five years of recent work experience as an HR Generalist, including two years in a manufacturing environment working with an hourly population</li><li>Strong knowledge of FMLA and workers comp laws</li><li>Bilingual fluency (English and Spanish) - Ability to read, write and speak</li><li>Proficient in PC skills, including Word, Excel, and PowerPoint</li><li>Ability to travel as needed to support business client groups (Approximately 25% domestic travel, which may require overnight stays)</li></ul> Education: <ul><li>BS or BA degree in human resources, business, or related field</li></ul>

Responsibilities: <ul><li>Scout opportunities to In-license and/or acquire clients (products) in India to run the businesses profitably with P&amp;L assessment.</li><li>Building business proposals, market evaluation, sales forecasting, pricing strategies, go-to market plan ensuring mutual income growth.</li><li>Search &amp; close contract sales &amp; marketing business opportunities generating revenue with help of head of partner business.</li><li>Capability to build a team of Project Managers &amp; training field personnel and handholding of end-users (wherever needed).</li><li>End-to-end development and delivery of new business pitches and presentations leading to bottom-line improvement.&nbsp;&nbsp;&nbsp;</li><li>Verifying the assumptions for products being evaluated by meeting KOLs.</li><li>Preparing evaluation report based on feedback.</li></ul> Requirements: <ul><li>Preferably MBA else Bachelor Degree with around 10+ years of relevant experience in B2B Business development from Pharma / Personal care / Healthcare / Medical services industry.</li><li>Proven track record of generating new business leads, work on new business leads, project management.</li><li>Proficiency in MS Office / CRM software / Power point presentation and data analysis.</li><li>Communication and negotiation skills.</li><li>Time management and planning skill.</li><li>Therapeutic &amp; Market knowledge.</li><li>Ability to build rapport.</li><li>Proficiency in English.</li></ul>

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117 training Jobs found

Regulatory Affairs Manager

Supply Chain Analyst

Laboratory Supervisor

125112 Assembly Vision System Engineer

127202 / 127203 Certified Quality Engineer

118175 Molding Manufacturing & Process Development Engineer

Lead Medical Affairs

Quality Engineer IV

Bi-Lingual HR Generalist

Business Development Manager – Partner Business

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Skills

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117 training Jobs found

Regulatory Affairs Manager

Supply Chain Analyst

Laboratory Supervisor

125112 Assembly Vision System Engineer

127202 / 127203 Certified Quality Engineer

118175 Molding Manufacturing & Process Development Engineer

Lead Medical Affairs

Quality Engineer IV

Bi-Lingual HR Generalist

Business Development Manager – Partner Business

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

EMPLOYER

TALENT

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Contact Us

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