- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and ... an effective implementation and oversight model to maintain best-in-industry regulatory compliance.The Vice President Regulatory Affairs ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … procedures. Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and Non-clinical ... Experience Level: 7+ years of relevant experience Minimum of 5 years clinical/ regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of statistical results and provide input on reporting (CSR) to support Medical Affairs and HEOR/HTA strategies: Plan, set-up and execute additional ... drug development and/or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting preferred- 4 or More Years Experience in… more
- ThermoFisher Scientific (Asheville, NC)
- …Bachelor's degree or 4+ years of experience in product compliance, quality, regulatory affairs , or engineering. **Suggested Experience** + Experience in ... Quality, Operations, Service, and other functions. This role supports integration of regulatory compliance requirements for laboratory and medical devices from… more
- Medtronic (Santa Rosa, CA)
- …industries and 5+ years of managerial experience Nice to Have + 10+ years of Medical Device regulatory affairs experience + An advanced degree ... + Bachelor's degree with minimum 7 years of regulatory affairs experience in healthcare, medical device or pharmaceutical industries and 5+ years of… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …in life sciences field preferred.) + Minimum 5 years of strong Regulatory Affairs experience in the medical device industry. + Proven prior experience ... **Job Description Summary** As Staff Regulatory Affairs Specialist, Infusion, you will...from regulatory agencies. + Working knowledge of medical device stand-alone software, device … more
- Olympus Corporation of the Americas (Westborough, MA)
- …other projects, initiatives and tasks. **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device industry is mandatory ... and more fulfilling.** **Job Description** The Specialist, I - Regulatory Affairs will support the maintenance of...+ Assign, review and maintain the EU Basic Universal Device Identifiers (BUDI). + Provide regulatory support… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …required. Master's degree in life sciences preferred. + 5 years of Regulatory Affairs experience in the medical device industry preferred + Working ... responsible for support of a variety of international related regulatory activities and projects, and/or personnel. This position is...knowledge of medical device stand-alone software, device interoperability and IEC… more
- Actalent (Osseo, MN)
- …projects. Hard Skills + +8 Years of Regulatory Affairs + +5 Years of Medical Device + +3 Years of New Product Regulatory Support (PMA) Soft Skills + ... Job Title: Regulatory Affairs Specialist Job Description In...MDR technical files, review product development materials, and create regulatory submissions for the active implantable medical … more
- Abbott (Maple Grove, MN)
- … device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for ... in clinical research, clinical affairs , regulatory affairs , or quality systems, in the medical device or pharmaceuticals industry. + 3-5+ years of… more
- Stryker (Fremont, CA)
- …7+ years' experience in an FDA regulated environment required + 5+ years' experience in medical device regulatory affairs required + RAC certification or ... benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) We are currently seeking a **Senior Staff Regulatory Affairs Specialist** to join our Neurovascular… more
- Philips (San Diego, CA)
- …years Regulatory Affairs experience within FDA regulated medical device /technology environments, including- regulatory approvals, submittals (eg, FDA ... The Principal Regulatory Affairs Specialist will play a...as needed. + Provide support as it relates to medical device submissions and certifications during product… more
- Teleflex (Morrisville, NC)
- …experience may be acceptable in lieu of a degree. * 7 to 10 years of related Medical Device Regulatory Affairs with experience in Class I and II ... Sr. Regulatory Affairs Manager - Product Management...directly to the company's growth and reputation within the medical device industry. **Principal Responsibilities** 1. Oversee… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …technical field Minimum 8-10 years' pharmaceutical or diagnostics experience including 3+ years IVD/ Medical Device Regulatory Affairs experience. Does ... data-driven human translational approach. The In Vitro Diagnostic (IVD) Regulatory Affairs (RA)Team along with the ...be for you if have:** + Experience authoring US Medical Device submissions (Q-sub, IDE, 510(k), PMA)… more
- Stryker (Portage, MI)
- …FDA regulated industry required; preferably with medical devices. + 7+ years of Medical Device Regulatory Affairs experience required. + Previous ... employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) We are currently seeking a **Principal Regulatory Affairs Speci** **alist** for our Instruments… more
- Teleflex (Morrisville, NC)
- …in a science or engineering field, or equivalent work experience. * 5+ years of Medical Device Regulatory Affairs experience, domestic and international. ... Sr. Regulatory Affairs Specialist **Date:** Jun 26,...:10562 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… more
- GE HealthCare (Waukesha, WI)
- …at least 6 years of relevant work experience) with 3 years of relevant experience in medical device regulatory affairs OR MR Engineering experience OR ... Characteristics** + Advanced degree in scientific, technology or legal disciplines + Regulatory Affairs Certification (RAPS) + Team-oriented and responsive to… more
- Abbott (St. Paul, MN)
- …Experience in post-market surveillance, risk management, clinical research, or regulatory affairs in medical device or pharmaceuticals industry. + ... for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more… more
- Stryker (Portage, MI)
- …in Medical Device . + A minimum of 3 years of Medical Device Quality or Regulatory Affairs experience required. + A Master's Degree or advance ... is available at www.stryker.com . We are currently seeking an **Associate** **Manager, Regulatory Affairs ** to join our **Acute Care business unit** , Hybrid,… more
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