- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746 Date: Jun 11, 2025 Location: Exton, Pennsylvania, US Department: ... regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and… more
- System One (Malvern, PA)
- …in life sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with management responsibilities. + Strong ... Job Title: Director of Regulatory and Medical Affairs ...Manage and maintain ongoing submissions such as annual reports, medical device facility registrations and device… more
- ManpowerGroup (Lake Forest, IL)
- …a leading organization in the medical device industry, is seeking a Regulatory Affairs / Operations Specialist to join their team. As a Regulatory ... and collaborative environment. + Gain experience in regulatory affairs within the medical device industry. + Develop skills in electronic submission… more
- Medtronic (Santa Clara, CA)
- …+ 15+ years of relevant progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry **or** an advanced degree ... of relevant progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry. + 10+ years of people leadership,… more
- Actalent (Piscataway, NJ)
- …+ 4+ years of work experience in quality assurance and/or regulatory affairs in the medical device , biotech, life sciences, or pharmaceutical ... Job Title: Quality Assurance and Regulatory Affairs SpecialistJob Description As a...industry. + Expertise and knowledge of clinical assays and/or medical devices in a regulated environment. + Working knowledge… more
- Canon USA & Affiliates (Lansing, MI)
- …including MS Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry required + Minimum Education ... ** Regulatory Affairs Specialist - Post Market...$72,000 to max $116,100 (annual equivalency) **_About us!_** _Canon Medical Systems USA, Inc., a world leader in diagnostic… more
- Stryker (Portage, MI)
- …Premarket Approval devices is highly desirable + Familiarity with European medical device regulations + Regulatory Affairs experience within Medical ... Stryker is hiring an **Associate Manager, Regulatory Affairs ** preferrable in **Portage, MI,**...Device preferred + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and international requirements +… more
- J&J Family of Companies (Santa Clara, CA)
- …* Other duties as assigned. **Requirements** * Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; ... Johnson is hiring for a **Sr.** ** Regulatory Affairs Specialist (Remote) - Shockwave Medical ** to...aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease… more
- J&J Family of Companies (Santa Clara, CA)
- …+ Other duties as assigned. **Requirements** + Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; ... aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease...for Shockwave Medical , Inc. (SWMI). The Sr. Regulatory Affairs Specialist combines knowledge of scientific,… more
- Caldera Medical (Westlake Village, CA)
- …Sciences, Biomedical Engineering, or a related field. * 5-7 years of regulatory affairs experience in the medical device industry. * Strong understanding ... Regulatory specialist, you will develop and implement medical device regulatory strategies to...Excel, Office, PowerPoint, and Adobe). * Regulatory Affairs Certification (RAC). Who is Caldera Medical ?… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and future approvals to management. **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device industry is mandatory. ... (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices… more
- Hologic (Marlborough, MA)
- …direct experience in Regulatory Affairs within the IVD or medical device industries. + Master's Degree in biomedical engineering and/or RAC preferred ... of 5-8 years direct experience in Regulatory Affairs within the IVD or medical ...Regulatory Affairs within the IVD or medical device industries. + Software/instrumentation experience strongly… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion technologies. ... * Minimum of 5 years of experience in Regulatory Affairs working with complex medical device systems and software strongly preferred. * Experience… more
- Imperative Care (Campbell, CA)
- …of education/training and experience. + An advanced degree or regulatory affairs experience in the medical device industry strongly preferred. ... Title: Sr Regulatory Affairs Specialist This position is...of experience in related roles at healthcare, pharma, or medical device industries; or an equivalent combination… more
- University of Utah (Salt Lake City, UT)
- …a 9-month (annually Aug. 16 - May 15) Career-line faculty position in the area of Regulatory Affairs , Medical Device Design and Regulatory Science. ... and strong interest in teaching Regulatory Affairs , Regulatory Science, and medical device design courses. Practical experience in regulatory … more
- Medtronic (Irvine, CA)
- …relevant experience + Or advanced degree with a minimum of 2 years of experience in medical device regulatory affairs **This is not a remote position** ... **Nice To Have** + 4 years of experience in medical device regulatory affairs + Excellent technical knowledge of medical products and understanding… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Staff Specialist, Regulatory Affairs , you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... of practical experience regulatory affairs , with a focus on medical device systems + Knowledge of international regulatory requirements (eg, FDA QSR,… more
- Philips (Murrysville, PA)
- …experience in Regulatory Affairs within Global FDA regulated medical device /technology environments, and a minimum of 3+ years' experience successfully ... The Regulatory Affairs Program Manager will play...program/project teams in maintaining Global enterprise compliance for Unique Device Identification (UDI). + You have demonstrated Regulatory… more
- Medtronic (Lafayette, CO)
- …years of experience in regulatory affairs **Nice to Have** + 4+ years of medical device regulatory affairs experience + Local to CO and willing ... Day in the Life** We are seeking a Senior Regulatory Affairs Specialist to join our team...Quality Management Systems (QMS) + Technical Writing + International medical device regulatory submission/approval experience,… more
- Stryker (Weston, FL)
- …3+ years of experience in an FDA regulated industry + 2+ years of experience in medical device regulatory affairs + Thorough understanding of FDA, ... Europe, and international medical device regulations + Experience drafting regulatory submissions...certification or Advanced Degree (Masters in Regulatory Affairs ) + Previous experience with Class II/III medical… more
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