Regulatory Affairs Manager

Fiber Optic Optic Product Development Engineer

Workplace Technology Engineer

Senior Business Analyst (SAP HCM)

118175 Molding Manufacturing & Process Development Engineer

123667 Test and Validation Engineer

121779/118601 Office Staff R&D/Product DVL Engineer (Relays)

Business Development Manager – Partner Business

Deskside Engineer L2

Signal Integrity Test Engineer

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>Product design, including but not limited to, fibre optic connector and termini design, fibre optic cable assembly design, fibre optic flex cable assembly design.&nbsp;</li><li>Support development of fibre optic interconnect systems&nbsp;&nbsp;</li><li>Liaison to Manufacturing plant locations&nbsp;</li><li>Create Engineering Change Requests (ECRs)&nbsp;&nbsp;</li><li>Make changes to drawings in SolidWorks/CREO/ZWCAD to support UK MIL or General Market Controlled ECR/ECNs&nbsp;</li><li>Address requests for product extensions, drawing changes, engineering quotes.&nbsp;</li><li>Handle requests to get part extended and costed SAP&nbsp;&nbsp;</li><li>Support Expanded Bean Product Line for changes and product extensions.&nbsp;</li><li>Create design verification test (DVT)/Qual test plans, create test request&nbsp;&nbsp;</li><li>Support/witness testing in the lab,&nbsp;</li><li>DVT/Qual cable assy design/drawings, component modeling/print creation,&nbsp;</li><li>Participate in DFMEA/PFMEA&nbsp;&nbsp;</li><li>Support design review preparation/presentation&nbsp;&nbsp;</li><li>Model shop requests&nbsp;</li><li>Support build or build prototype parts.&nbsp;&nbsp;</li><li>Working knowledge of manufacturing processes.&nbsp;</li><li>Proficient with MS Office software.</li></ul> Requirements : <ul><li>Fiber optic or rugged fiber optic connector and termini development background</li><li>Degree in appropriate discipline or equivalent work experience with fiber optic connectors, cables, termini, etc&nbsp;</li><li>Fiber optic cable assembly development experience&nbsp;</li><li>Support and lead product development through the product development life cycle&nbsp;</li><li>Experience with Solid works, CREO and Autocad&nbsp;&nbsp;</li><li>Tolerance analysis&nbsp;&nbsp;</li><li>5-8 years design and new product development experience, preferably with electronic or optoelectronic related assemblies, hardware, and components</li></ul>

Responsibilities: <ul><li>Design and execute the standardization of workplace and infrastructure solution across the group, taking into consideration industry best practices and regulatory requirements.</li><li>Implement and manage workplace technology solutions including end users devices, telephony, collaboration and office productivity tools, managed print. </li><li>These will include the focus on Microsoft 365 suite, including emerging technologies like Microsoft Co-Pilot.</li><li>Implement and manage network infrastructure such as WAN, Enterprise LAN, firewalls, routers, switches, load balancers, remote access and other network enabling technologies and applications.</li><li>Implement and manage the Service Desk to handle service requests and incidents.</li><li>Drive workplace technology and infrastructure service recovery to reduce system downtime and impact to internal users and external customer.</li><li>Track service providers SLAs.</li><li>Experimentation and recommendation of new workplace technologies. Keep abreast with technology development in the industry and regulators.</li></ul> Requirements: <ul><li>Bachelors degree in Computer Science, Information Technology, or a combination of relevant professional experience.</li><li>More than 5 year’s relevant working experience in managing Workplace Technology and infrastructure. Financial services industry experience preferred but not mandatory.</li><li>Experience in implementing and managing Microsoft infrastructure (i.e. Microsoft 365), including Active Directory, ADFS, Azure AD, SCCM, end point management tools.</li><li>Familiar with WAN routing protocols, QOS, COS and experienced with Telco’s business and operations and network protocols like DHCP, TCP/IP, and VPN.</li><li>Relevant certifications in Workplace Technology and Networking preferred but not mandatory.</li><li>Strong technical, analytical and engineering competencies with hands-on experience in managing workplace and infrastructure environments.</li><li>Customer and service centric and able to communicate concisely and clearly with non-IT-savvy users.</li><li>Knowledge of ITIL framework and IT service management concepts and Agile methodologies.</li></ul>

Responsibilities: <ul><li>Plan and execute Change Requests activities which include gather and facilitate business process discussion, conduct detailed analysis, solution design, development and configuration, testing, documentation and deployment.</li><li>Provide application support to end users in troubleshooting and resolution of issues, and updating them of the progress which entails communicating with them in an appropriate and constructive manner.</li><li>Work closely with the team and business partners to fully understand the user functionality, pain points, and areas of improvements within our applications</li><li>This role includes implementation and sustainment responsibilities.</li><li>Travel within Asia Pacific region will be expected but kept to a minimum.</li></ul> Requirements:&nbsp; <ul><li>Minimum 8 years’ experience in SAP HR/HCM project implementation and rollout experience</li><li>Strong understanding of SAP HCM process and local statutory reporting and audit requirements</li><li>Strong functional and configuration skills in all areas of the HR/HCM modules</li><li>Able to do simple debugging of program</li><li>Experience in supporting interfaces between SAP and non-SAP applications</li><li>Team player with good writing, verbal communication and presentation skills.</li><li>Independent, resourceful and able to perform under pressure with minimal supervision.</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>Subject matter expert in high-speed test systems and validation activities through product development cycles</li><li>Establishing testing requirements for new products based on electrical and software specifications</li><li>Development of high-speed cables test systems/fixtures from conception to manufacturing deployment</li><li>Test system architecture, system diagramming, test software, hardware build, and validation into manufacturing of product</li><li>Creating actionable recommendations based upon design reviews and product specifications</li><li>Making data driven decisions about the product functionality and areas for improvement.</li></ul> Requirements: <ul><li>Bachelor’s degree in Electrical Engineering, Master’s degree preferred</li><li>Minimum of 10+ years of work experience in a high-speed test engineering role&nbsp;</li><li>Experience with cable/cable assembly designs (high speed twin-ax cables, direct attach copper (DAC) cables, active copper cables)</li><li>Experience with high speed test equipment (Digital Sampling Oscilloscope, Vector Network Analyzer, Bit Error Rate Tester, TDR, Pattern Generators, Power Supplies, etc.)</li><li>Strong experience with Python</li><li>Strong analytical capabilities to interpret test/lab data to identify issues and provide solutions to fix identified problem.&nbsp;&nbsp;</li><li>Experience in project leadership, especially as it applies across design, development &amp; manufacturing teams</li><li>Excellent verbal and written communication skills</li><li>Ability to work in a global environment – able to accommodate varying time zones, fluent in English (verbal/written), able to collaborate with individuals across geographies</li><li>Individual must be highly motivated, a quick learner, and able to work independently</li></ul>

Responsibilities: <ul><li>Designing and developing new products to meet customer requirements within scope, schedule, and budget constraints by following company Lean PD process.</li><li>Innovating original ideas and design proposal for new products, studying the feasibility of customer specifications.</li><li>Leading new product technical data output, such as: 3D, 2D drawing and Design objective.&nbsp;</li><li>Initiating product design document, such as: PRD, DV/PV plan, Product review, Initial BOM, DFMEA and Significant Characteristic.&nbsp;</li><li>Leading product design review with function team and technical review with customer, and communicating with supplier feasibility study of components material.&nbsp;</li><li>Performing engineering calculations to analyze and describe product to ensure robust design with economic cost.</li><li>Working with FAI approvals, technical risk analysis, supporting 8D report and 5 WHY analysis, judging manufacturing deviations and making decisions on deviation acceptance.</li><li>Improving and enlarging existing products, quality improve and manufacture engineering support. Helping resolve technical problems or providing solutions of avoiding problems to ensure accurate implementation of production.</li><li>Understanding HV contactors testing procedures and equipment, reviewing evaluation or test report and confirming accuracy of report contents to ensure product meets quality specification.</li><li>Reviewing patent searches to evaluate patentability of proposed designs to ensure that others patents are not infringed upon.&nbsp;&nbsp;</li><li>Providing innovative solutions to reduce product cost, improving product quality, and improving process efficiency, documents and communicates potential IP to ensure company IP is protected.</li><li>Providing technical support to customers and Sales Engineers to ensure proper application of products in the field.</li><li>Lead and guide junior engineers to finish comprehensive task, work out design guidelines and lesson learned.</li></ul> Requirements: Education: <ul><li>Bachelor degree or above</li><li>Mechanical Engineering and Electronic Engineering preferred</li></ul> Qualification &amp; Certification: <ul><li>CET-6 or equivalent Level</li><li>6 Sigma Black Belt is a plus</li><li>Be familiar with related automotive standards such as IEC61810 and IEC60664 , LV124 etc.</li></ul> Experience: <ul><li>At least 5 years of relevant work experience for bachelors, at least 3 years of relevant work experience for masters.</li><li>More than 3 years of experience in contactor design and manufacturing, with successful cases of independent of contactor design</li><li>Familiar with the project development process and related document output in the automotive industry</li></ul> Technical Skill &amp; Competencies: <ul><li>Be familiar with product development process and HV Contactor manufacturing process.</li><li>Understanding of special characteristic significance for customer and TE</li><li>Understanding of basic automotive industry core tools, such as APQP, FMEA and PPAP.</li><li>The completed understanding and wide application of technical theories, principles, engineering tools and techniques, such as: GD&amp;T, DFM, DFA, DFSS, etc.</li><li>Ability to skillful use Creo software and drawing design, tolerance calculation.</li><li>Familiar with key knowledge of high-voltage contactor development, such as coil and electromagnetic system design, Electrical contact design, arc extinguishing design, auxiliary contact design and integration</li><li>design with circuit breaker, etc</li><li>Understanding of relevant technical standards and law regulations.</li><li>Ability to build strong internal/external working relationship.</li><li>Effective Interacts and communication within the team.</li><li>Familiar with Energy-saving contactor circuit design (PWM &amp; dual coil), the matching test of contactor and fuse.</li><li>Familiar with the relevant process of contactor production and the setting of process parameters</li><li>Have certain project management ability to ensure the timely and high-quality completion of the project</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>

Responsibilities: <ul><li>Provide L2 helpdesk and onsite support to users on desktop, laptop, mobile and peripherals</li><li>Update software patches periodically</li><li>Provide services for all iMac, Deskside Break Fix support for end user devices and peripherals including delivery processing in accordance with Service Level by location</li><li>Provide and/or oversee, as appropriate all installations and de-installations</li><li>Provide and/or oversee cascades, moves, additions, refurbishments and operational changes for all in-scope equipment software, and related services at designated customer sites</li><li>Coordinate, plan and schedule iMac in support of office changes, staff onboarding/offboarding with all IT functions and/or third-party vendors to minimise operational interruption or disturbance to customers</li><li>Prepare and be on standby for video conference and meeting room A/V</li><li>Assist in any IT-related projects, activities and events</li></ul> Requirements: <ul><li>Candidates with work rights in Singapore i.e Singapore Citizen and/or Singapore Permanent Resident due to nature of role</li><li>Relevant technical certification in end-user computing</li><li>At least 3 years in a role of similar capacity</li></ul> Preferred Requirements: <ul><li>Knowledge and hands-on experience with Microsoft end-user technology</li><li>Knowledge and hands-on experience with iOS end-user technology</li><li>ITIL-certified</li></ul>

Responsibilities: <ul><li>Review and confirm the test specification of new projects. Evaluate the test requirement of new projects.</li><li>Design and set up test systems for new projects.</li><li>Work with US team for test issues.</li><li>Control all testing equipment and fixtures for electrical lab.</li><li>Monitor all electrical testing process.</li><li>Prepare testing plan. Review test results.</li><li>Ensure test data integrity and proper reporting.</li><li>Solve problems on test.</li><li>Define test methods for new projects, deliver the new test methods to technicians and operators.</li><li>Get training from outside and deliver it inside.</li><li>Improve test process.</li><li>Support on lab management improvement. Develop the test capacity of the electrical test lab.</li></ul> Requirements: <ul><li>Bachelor’s degree, preferably major in electronic information technology or computer.</li><li>Adept in hardware test methodologies, especially for electrical and SI test.&nbsp;</li><li>Good experience in C#, Python or VB, can create software to do test/analysis easier.</li><li>Adept in test equipment: TDR (Time Domain Reflectometer), NA (Network Analyzer), Oscillograph, Data Timing Generator, LCR Meter, Hi-pot, Milliohm Meter, Microohm Meter, Megohm Meter, Thermal Chamber.</li><li>Adept in signal integrity test. Familiarity with the elements and testing methods of Insertion Loss, Impedance, Return Loss, Time Delay Skew, SCD21.......</li><li>Familiarity with the product verification testing. Good experience in setting up new test system, drafting test plans and documents.</li><li>Good measurement capability and analysis capability.&nbsp;</li><li>Familiarity with standards and products, such as QSFP, SFP+, PCI-E, DisplayPort, HDMI, SATA, Minis-SAS, USB…</li><li>Adept in MSA.</li><li>Fluent English both in verbal and written.</li><li>Strong PC skills. Adept in hardware and software. Adept in MS Office.</li></ul>

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135 software applications Jobs found

Regulatory Affairs Manager

Fiber Optic Optic Product Development Engineer

Workplace Technology Engineer

Senior Business Analyst (SAP HCM)

118175 Molding Manufacturing & Process Development Engineer

123667 Test and Validation Engineer

121779/118601 Office Staff R&D/Product DVL Engineer (Relays)

Business Development Manager – Partner Business

Deskside Engineer L2

Signal Integrity Test Engineer

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Skills

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135 software applications Jobs found

Regulatory Affairs Manager

Fiber Optic Optic Product Development Engineer

Workplace Technology Engineer

Senior Business Analyst (SAP HCM)

118175 Molding Manufacturing & Process Development Engineer

123667 Test and Validation Engineer

121779/118601 Office Staff R&D/Product DVL Engineer (Relays)

Business Development Manager – Partner Business

Deskside Engineer L2

Signal Integrity Test Engineer

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

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