- Merck & Co. (Rahway, NJ)
- …collaboration with multiple internal stakeholders across HH, our Research & Development Division, Medical Affairs , Regulatory , Legal etc. as well as external ... use of the digital pathology tools in collaboration with Medical Affairs and our Research & Development...sciences and/or healthcare space Understanding and experience with global regulatory requirements for Medical Device … 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
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …degree or equivalent. Science background preferred. Experience: 1+ years in regulatory affairs or equivalent. Medical device /IVD industry preferred. ... Essential Job Duties and Responsibilities: + Organize, update, and maintain regulatory documentation in accordance with company policy and procedures. + Assist in… more
- Medtronic (Minneapolis, MN)
- …degree in a technical discipline + Minimum 4 years of experience in regulatory affairs in the medical device industry with Bachelor's degree + Minimum 2 ... years of experience in regulatory affairs , in the medical device industry with Master's degree Nice To Have + Experience working in regulated,… more
- Medtronic (Mounds View, MN)
- …profile. + Bachelor's degree required + Minimum of 7 years of experience in regulatory affairs in the medical device industry + Or minimum 5 years of ... PRINCIPAL REGULATORY AFFAIRS SPECIALIST - CARDIAC SURGERY...medical device regulatory experience with an advanced degree...medical device regulatory experience with an advanced degree Nice to Have… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …(or similar) is required. Master's degree preferred. + Experience in Regulatory Affairs within the medical device industry (minimum 5 years), with ... live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care...it is likely not legitimate._ **Job Description** The Global Regulatory Affairs Operations Manager, is responsible for… more
- J&J Family of Companies (Raynham, MA)
- …NA-US-Massachusetts-Raynham **Organization** Medical Device Business Services, Inc (6029) **Job Function** Regulatory Affairs **Req ID:** 2406183699W ... Regulatory Affairs Specialist I (Depuy Synthes/Spine) - Medical Device Business Services, Inc. (1 of 2) - 2406183699W **Description** DePuy Synthes, part… 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
- Actalent (Laguna Hills, CA)
- Description: This position is a regulatory affairs specialist for a medical device company. Individual must be knowledgeable in medical device ... the development process. Skills: regulatory submission, medical device , fda, Regulatory affairs , Regulatory compliance Top Skills Details: … 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
- 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
- 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
- System One (Pleasanton, CA)
- …5 years of experience in regulatory affairs in IVD or medical devices. IVD device experience is preferred. + Experience with Microsoft based applications ... Affairs Specialist III will manage activities associated with regulatory approval of in vitro diagnostic medical ...approval to market devices + Responsible for assessment of device changes for regulatory implications. Requirements +… 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
