- Teleflex (Morrisville, NC)
- …in a science or engineering field, or equivalent work experience. - 5+ years of Medical Device Regulatory Affairs experience, domestic and international. ... Senior Regulatory Affairs Specialist **Date:** Nov 3,...- The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose… more
- Terumo Medical Corporation (Somerset, NJ)
- …assigned clinical reports, documents and scientific presentations in cooperation with the Clinical, Medical , & Regulatory Affairs Teams, Key Opinion Leaders ... include Clinical Affairs , Professional & Clinical Education, Regulatory Affairs , Quality Systems, Marketing, Sales as...a medical writer for pharmaceutical, CRO, or medical device clients, a strong plus. **Nearest… more
- embecta (Parsippany, NJ)
- …discipline (eg engineering, bioengineering, biology, chemistry). + 5+ years Regulatory Affairs experience in medical device companies. + Must have ... in both the US and Europe, and related regulatory affairs activities to ensure compliance with...current knowledge of the US and European Medical Device regulations. + Demonstrated success in… more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director, Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device ...externally with a solid background in medical devices /diagnostic development regulations and associated regulatory deliverables.… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Minimum of 10 years of Regulatory Affairs experience, ideally within the medical device or digital health industries. + Minimum of 3 years focused on ... medical devices . This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies for digital… more
- Olympus Corporation of the Americas (Westborough, MA)
- …in engineering or life sciences required. + Minimum of 7 years prior regulatory affairs experience in the medical device industry, or a minimum of 5 ... to the digital transformation in the medical device space. The role focuses on executing regulatory...sensitivity to cultural differences. + Familiarity with digital health regulatory frameworks for medical devices … more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ BS or comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device or digital health industries. + ... solutions, including Artificial Intelligence (AI) exempt from the medical device classification, and connected technologies. + Provide regulatory guidance,… more
- Lundbeck (Deerfield, IL)
- …products in development by providing substantive advice to US operations, including Marketing, Medical Affairs and Regulatory Affairs departments, ... agreements, consulting agreements, corporate agreements, confidentiality agreements and certain medical affairs agreements. + Serves as legal representative… more
- Terumo Neuro (Aliso Viejo, CA)
- **13011BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for establishing, preparing, and leading the strategy for worldwide product ... solutions. + Coach, review, and delegate work to junior regulatory affairs professionals; may manage large projects...by multiple successful US FDA Class II / III medical device submissions, EU CE Mark applications,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …closely with cross-functional teams, including sales, marketing, medical affairs , market access and policy/advocacy (MAPA), regulatory affairs ... Nordisk's Rare Disease portfolio. The Rare Disease portfolio includes medical treatments, customer solutions, and devices across...drive market share and revenue growth. Partner with legal, regulatory , and medical affairs for… more
