- Sanofi Group (Morristown, NJ)
- …Sciences or other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs , with 5+ years specifically ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...without relying on authority, including participating in cross-functional groups ( medical , legal, regulatory , etc.) to lead toward… more
- GRAIL (NJ)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals. + Effective… more
- Pentax Medical (Montvale, NJ)
- … and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an established medical ... future of medical technology. Responsibilities of Senior Regulatory Affairs Specialist : + Coordinate with...regulated employer + Thorough understanding of domestic and international regulatory requirements for medical devices … 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
- IQVIA (Parsippany, NJ)
- …data, etc.), HCP engagement by life sciences companies. Expertise in domains adjacent to medical affairs , such as regulatory or pharmacovigilance, would also ... **Manager, Medical Affairs Strategy** **Overview** IQVIA is...diverse client base includes the global top 20 pharmaceutical, medical device , and biotechnology companies as well… 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
- Bayer (Trenton, NJ)
- …As the Director of Regulatory Affairs , you will represent our medical device regulatory team within the Molecular Imaging platform. This pivotal ... required + Direct professional experience in Regulatory Affairs within the medical device ... device industry, with significant experience involving medical devices pumping systems, or software-driven electromechanical… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and develop **use-related risk analysis (URRA)** and mitigation strategies in partnership with Medical & Regulatory Affairs . + Collaborate with ** ... Validation &** **Human Factors strategies** for successful submission in concert with Regulatory Affairs . + Conduct **gap analyses** of existing DVal/HF… more
- Sanofi Group (Morristown, NJ)
- …teams + Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part ... **Job title** : Global Regulatory Affairs Device Lead...to internal regulatory processes and procedures for medical devices + Accountable for regulatory… more
- J&J Family of Companies (Raritan, NJ)
- …health authorities concerning clinical/ medical issues + Assists Regulatory Affairs in the development of drug/ device regulatory strategies + ... via matrix interactions also includes individuals from project management, operations, regulatory affairs , data management, medical writing, biostatistics,… more