- Merck & Co. (Rahway, NJ)
- …and design verification testing to develop value-added solutions for medical devices and combination products.Build and enhance device or combination product ... and project management in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors,… more
- Merck & Co. (Rahway, NJ)
- …formulation science, preclinical and clinical research.In-depth knowledge of medical device development, regulatory requirements, and quality standards, ... strategies.Strategic Planning and Execution:Provide strategic leadership in the development of medical devices and drug- device combination products, aligning… more
- Merck & Co. (Rahway, NJ)
- …development including regulatory submission and approval processes. Including development drug- device combination product or a medical device component ... their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Level: Requires 9+ years of relevant experience. Minimum of 8 years clinical/ regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO ... Medical Writer will work closely with cross-functional project teams, including Medical & Science, Clinical Operations, Biometrics, and Regulatory Affairs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Experience Level: 7+ years of relevant experience Minimum of 5 years clinical/ regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO ... Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management, and Non-clinical Development.… more
- Moffat Workforce (Plymouth, MN)
- …1 or more years of Inspection experience in a medical device environment. Some experience using associated measurement devices (microscope, caliper, laser ... (AX). Participate in external audits advocating the company (Customer, 3rd party, Regulatory ). Other activities and responsibilities as assigned. Quality Control… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position has advanced experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry across multiple therapeutic areas and ... years with Master's Degree) data management and/or related work experience in a medical device or pharmaceutical company, or similar environment (eg, CRO)… more
- Insmed Incorporated (San Diego, CA)
- …fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management ... support associated investigations, including: temperature excursion assessments, client and regulatory requests, and investigational testing. Assist in creating a… more
- Novo Nordisk Inc. (Atlanta, GA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Sally Beauty Holdings (Argyle, TX)
- …with Tax Department /Distribution Centers to obtain licenses for OTC products, medical devices , and dietary supplements, etc. Knowledge, Sklls and Abilities: ... in YOU. Join us." Primary Duties: Ensure product safety, quality and regulatory compliance of Private label...a competitive salary and outstanding benefits package that includes medical , dental, vision, life Insurance, paid vacation and sick… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …minimum of one (1) year related experience in medical device , biopharmaceutical, or pharmaceutical industry.Good understanding of regulatory requirements, ... of multiple myeloma.Legend Biotech is seeking QC Technician as part of the Quality Operations team based in Raritan, NJ. Company IntroductionFrom the very beginning,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the ... of the equipment and takes actions to optimize the output, reliability, quality , performance. He/she makes proposals for Continuous improvement and gets to work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and manlifts, and hand and power toolsRepair of instrumentation, electrical devices , circuits, and switchgear used in cGMP and nonGMP systemsInvestigate, ... theory, thermal energy principals, mechanical maintenancetechniques, and electromechanical theoryEnsures regulatory and job training remains current by promptly completing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... with Dx partner, or other supplemental studies to support development of Dx devices under design control process. They will lead identification and selection of Dx… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …is currently admitted to practice in that jurisdiction. + 8+ years of relevant medical device regulatory law experience + Ability to effectively communicate ... and other regulatory issues specifically related to medical devices and/or diagnostics throughout the lifecycle...home-use medical devices , and durable medical equipment + Experience supporting RA and Quality… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …experience in FDA and other regulatory issues specifically related to medical devices and/or diagnostics throughout the lifecycle of the product, including ... will serve as a strategic legal partner to BD's Regulatory , Quality , Medical Affairs, Sales...navigate controversial situations and negotiations + Deep understanding of regulatory requirements for connected device solutions, including… more
- Kelly Services (Bridgewater, NJ)
- …for new/updated departmental procedures and processes. + Liaise with internal functions ( Quality , Regulatory , Medical Affairs, Clinical) to gather critical ... **EU- Medical Device Regulation (MDR) Specialist** Kelly(R) Science & Clinical is seeking an **EU-MDR Specialist** for our client in Bridgewater, NJ. If you're… more
- AbbVie (Irvine, CA)
- …and strategy (eg, Pharma and Medical Device Regulation) for medical products to support global regulatory plans. + Coordinates across the Allergan ... as applicable. In addition, the incumbent is the key regulatory contact for Quality , Medical ...scientific discipline is highly desirable. + 8 years of regulatory experience in the medical device… more
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