- 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
- 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
- embecta (Parsippany, NJ)
- …changes, internal audits, or process improvements. + Ensure documentation adheres to global medical device regulatory requirements, including FDA 21 CFR Part ... workflows to enhance efficiency and compliance. + Collaborate with Quality, Manufacturing, Marketing, Medical Affairs , R&D, and Regulatory Affairs teams… more
- Organon & Co. (Jersey City, NJ)
- …years of industry experience? in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + ... leading the development or life-cycle management of drugs or devices which improve human health. The program manager may...plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical ,… more
