- embecta (Parsippany, NJ)
- …or technical discipline (eg engineering, bioengineering, biology, chemistry). + 5+ years Regulatory Affairs experience in medical device companies. + ... devices in both the US and Europe, and related regulatory affairs activities to ensure compliance with...Experience negotiating with Health Authority personnel in the medical device area. + Demonstrated global perspective, customer… more
- embecta (Parsippany, NJ)
- … changes, internal audits, or process improvements. + Ensure documentation adheres to global medical device regulatory requirements, including FDA 21 CFR ... to enhance efficiency and compliance. + Collaborate with Quality, Manufacturing, Marketing, Medical Affairs , R&D, and Regulatory Affairs teams to ensure… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the… more
- Sanofi Group (Morristown, NJ)
- …we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves ... **Job Title:** Global Regulatory Affairs CMC...**Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham,...GRA CMC Lead within our GRA CMC & GRA Device Organization, you'll drive global regulatory… more
- Sanofi Group (Morristown, NJ)
- …skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting ... pathways. The team is accountable for developing and implementing global regulatory strategies for device ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- J&J Family of Companies (Raritan, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Global Regulatory Affairs Diagnostics. This position is a hybrid ... candidates from any location to apply. The Associate Director, Global Regulatory Affairs Diagnostics will...submission of investigational and new in vitro diagnostic medical device applications to the regulatory authorities. This… more
- Bayer (Whippany, NJ)
- …technology and strategic regulatory leadership. As the Director of Regulatory Affairs , you will represent our medical device regulatory team within ... + Compliance & Policy Contribution: Actively contribute to shaping global regulatory compliance policies and procedures that...quality systems are required + Direct professional experience in Regulatory Affairs within the medical device… more
- Sanofi Group (Morristown, NJ)
- …other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs , with 5+ years specifically within advertising ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Medical Affairs Director - Oncology **Location:** Cambridge, MA / Morristown, NJ **About the job** **About us:** In order to pursue ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs ...unmet needs. Sanofi is recruiting a new Director in Global Medical Affairs (GMA) based in Cambridge,… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Description** We are **the makers of possible** ! BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ (TM) is ... possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve....directly to the business unit Vice President of Medical Affairs , the Director of Medical Affairs has… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …the core team, aiding product development, remediation projects, and meeting medical device regulatory needs. + Review, comprehend, and compose performance and ... role in crafting the future of medical technology and making a tangible impact on global health. **Responsibilities:** + Present the medical affairs role within… more
- IQVIA (Parsippany, NJ)
- **Manager, Medical Affairs Strategy** **Overview** IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services ... of innovative medical treatments. Our diverse client base includes the global top 20 pharmaceutical, medical device , and biotechnology companies… more
- Kelly Services (Bridgewater, NJ)
- …obtaining regulatory approvals + Knowledge of pharmaceutical, consumer or medical device industry regulatory affairs discipline throughout the product ... ** Regulatory Affairs Specialist Labeling** Kelly(R) Science...SKILLS** + Knowledge of pharmaceutical, consumer or medical device industry product labeling processes for review and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …510(k), Q-Sub), EU technical documentation under MDR, and other global regulatory filings. + Evaluate medical device regulations and lead the development ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist will represent...change control, ensuring compliance with US, EU, and other global regulatory requirements. + Author FDA submissions… more
- J&J Family of Companies (Raritan, NJ)
- …within the medical device industry and with clinical evaluation report regulatory requirements **required** ; thorough understanding of global medical ... Market Surveillance, Clinical Affairs , Design Quality Engineers, R&D, and Regulatory Affairs relating to literature search and systematic review processes.… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Validation &** **Human Factors strategies** for successful submission in concert with Regulatory Affairs . + Conduct **gap analyses** of existing DVal/HF ... **use-related risk analysis (URRA)** and mitigation strategies in partnership with Medical & Regulatory Affairs . + Collaborate with ** Regulatory Affairs… more
- J&J Family of Companies (Raritan, NJ)
- …for worldwide health authorities concerning clinical/medical issues + Assists Regulatory Affairs in the development of drug/ device regulatory strategies ... matrix interactions also includes individuals from project management, operations, regulatory affairs , data management, medical writing, biostatistics,… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …including Quality Engineering, WW Supplier Quality Assurance, Research and Development, Regulatory Affairs , and additionally to corporate functions, ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...related discipline + At least 3-5 years of medical device , biologic, pharmaceutical, or diagnostic industry experience. **Knowledge and… more
