- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director, Device Quality & Regulatory will play a pivotal leadership role within the organization, overseeing the quality ... mitigation activities. Regulatory CMC OversightLead the preparation and submission of high- quality regulatory CMC device content for global submissions,… more
- Merck & Co. (Rahway, NJ)
- …DescriptionPosition Title -Director/ Principal Scientist, Regulatory Compliance Department - Device Quality & Regulatory Brief Description of Position- ... This position will be part of the Device Quality & Regulatory Team... regulatory compliance for the company's portfolio of medical devices and medical device … more
- Merck & Co. (Rahway, NJ)
- …in method development, validation, and testing within the pharmaceutical, medical device , or combination product (preferred) industry.Demonstrated leadership ... (CoE) focused on developing and validating platform and innovative device /CP functional test methods with high technical rigor to...& Development (AR&D), Design Controls & Risk Management (DCRM), Quality , Regulatory , and Quality Control… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of 5D strategies with broader TA and asset plans Work collaboratively with medical , market access, regulatory , legal, compliance, privacy and public affairs ... Lead will be responsible for developing and implementing a Data, Diagnostics, Drug, Device , and Digital strategy and execution for relevant TAs, aligned closely with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as well as significantly contributing to the strategic vision of Clinical Medical Regulatory (CMR) Strategic Operations. Overall responsible for activities ... About the Department The Clinical, Medical and Regulatory (CMR) department at...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Aequor (Thousand Oaks, CA)
- …in Electrical/Mechanical /Biomedical Engineering Computer Engineering or equivalent experience Medical device and/or combination product development experience; ... deliverables are completed on time and adhere to high quality standards.Scope includes a wide range of devices, such...qualified candidate will coordinate technical teams to ensure successful device development of these medical devices. The… more
- Merck & Co. (Rahway, NJ)
- …and demonstrated experience partnering for Pharmaceutical development / CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …practices required- 4 or more years Clinical data management experience in a medical device , pharmaceutical company, or similar environment (eg, CRO); oncology, ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in science or related fieldA minimum of one (1) year related experience in medical device , biopharmaceutical, or pharmaceutical industryMust be able to work 2nd ... shift, 4PM-2:30AMGood understanding of regulatory requirements, policies and guidelinesWorking knowledge of Quality systemsExperience in use of eLIMS or similar… more
- West Pharmaceutical Services (Tempe, AZ)
- …biology or equivalent. + Significant experience (10+ years) in medical device /pharmaceutical manufacturing, quality assurance, regulatory affairs, or a ... Sr. Quality Manager Requisition ID: 66480 Date: Nov 2,...Abilities:** + ** Regulatory Skills:** In-depth knowledge of medical device and pharmaceutical regulations and guidelines,… more
- Merck (Columbus, OH)
- **Job Description** The Executive Director, Device Quality & Regulatory will play a pivotal leadership role within the organization, overseeing the ... quality assurance and regulatory CMC for complex medical devices, including...CMC Oversight + Lead the preparation and submission of high- quality regulatory CMC device content… more
- Merck (Columbus, OH)
- …**Position Title** -Director/ Principal Scientist, Regulatory Compliance **Department** - Device Quality & Regulatory **Brief Description of Position-** ... This position will be part of the Device Quality & Regulatory Team... regulatory compliance for the company's portfolio of medical devices and medical device … more
- Takeda Pharmaceuticals (Boston, MA)
- …a device and/or combination product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC; international experience ... management with a focus on Human Factors, ensuring that regulatory filings are of high quality and...meetings with global health authorities + Reviews and approves medical device development design control documentation, including… more
- Takeda Pharmaceuticals (Boston, MA)
- …or Engineering Discipline, higher degree preferred + 10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience ... landscape in US to maintain contemporary knowledge of global medical device and combination product regulations, standards,...scientific, regulatory and business issues to ensure regulatory filings are of high quality and… more
- AbbVie (Pleasanton, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Medical Device Quality Intern Overview Envision spending your ... products to protect patients worldwide. The Medical Device Combo Product Research and Development Quality ...works collaboratively and strategically with colleagues in R&D, Operations, Regulatory Affairs, Medical Safety and more to… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: Manager, Medical Device Quality Systems is responsible for supporting ... the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical...emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory … more
- AbbVie (Irvine, CA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: Manager, Medical Device Quality Systems is responsible for supporting ... the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical...emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory … more
- Adecco US, Inc. (Las Vegas, NV)
- …standards and customer specifications in the aerospace and medical device sectors. This role involves leading quality assurance initiatives, developing ... regular audits, inspections, and assessments to monitor compliance with quality standards and regulatory requirements. . Collaborate...experience in quality management, preferably in the medical device or aerospace industry. . Strong… more
- Terumo Medical Corporation (Somerset, NJ)
- …member of the TMC Quality Management Leadership Team. 2. Oversee medical device complaint processing in compliance with applicable regulations and standards ... develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- Merck (Wilson, NC)
- …products. + Experience with injection molding and working with medical device suppliers. + Experience leading Quality Management System gap assessments ... MDCP Operations Lead position will serve as the primary medical device and combination product (MDCP) point...liaison between the site and global MDCP teams (Technical, Quality , etc.), providing hands-on shop floor perspective and advocating… more
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