- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …compliance, product development, and clinical validation. **Key Responsibilities:** + Strategic Medical Leadership: Drive medical affairs activities ... support safety, efficiency, and clinical performance claims. + Global Medical Affairs Support: Ensure comprehensive Medical...+ At least 3 years of experience in the Medical Device /In Vitro Diagnostics industry. + Minimum… more
- Fujifilm (Trenton, NJ)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- Integra LifeSciences (Princeton, NJ)
- …both US and international, is essential, along with familiarity with regulatory affairs processes. Responsibilities include performing data analysis, managing ... uploads and verification, and ensuring high-quality, timely support for the Global Regulatory Affairs function and broader organizational compliance at Integra… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of ... projects and issues affecting development of new products or medical devices or new indications for existing products +...years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …decisions and guide product strategy -- May include cross-functional collaboration with R&D, Medical Affairs , Market Access, Regulatory Affairs and ... (eg, presentations/publications focused on surgical device modeling, ISPOR Surgery or Medical Device SIG). + Has substantial hands-on experience planning and… more
- Bausch + Lomb (Trenton, NJ)
- …Management, Clinical/ Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, Pharmacovigilance/GPSS and Drug/ Device Safety, and Clinical ... in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … compliance throughout the product lifecycle. The individual collaborates cross-functionally with Regulatory Affairs , Medical Affairs and Marketing ... critical role ensuring product safety and compliance in the medical device industry. **Responsibilities** + **Lead Post-Market...+ ** Regulatory Knowledge:** Extensive understanding of FDA medical device regulations (21 CFR Part 820),… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , ... in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is… more
- J&J Family of Companies (Raritan, NJ)
- …profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... and deliverables for registration sample packs, Software as a Medical Device (SaMD), and other non-U.S. labeling...partnership with Global Labelling Product Leaders, Supply Chain, Marketing, Regulatory Affairs , CMC Regulatory … more
- J&J Family of Companies (Raritan, NJ)
- … medical device industry + Good working knowledge and understanding of medical device regulations, standards, and regulatory bodies, eg FDA (Food and ... other SOPs, balancing flexibility, efficiency, and speed, while adhering to applicable medical device industry regulations. This person will represent R&D for… more