- 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
- 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
- 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
- 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
- Pentax Medical (Montvale, NJ)
- …devices and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an established medical ... for Endoscopes and Speech, Voice and Swallowing devices, meet global regulatory standards. This role will collaborate...shaping the future of medical technology. Responsibilities of Senior Regulatory Affairs Specialist : + Coordinate with… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Staff RA Specialist will represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform on ... regulatory strategies to collaborators. + Support development and execution of global regulatory strategies by collaborating closely with international … 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
- Bristol Myers Squibb (Madison, NJ)
- …in pharmaceutical (medical device , biologics) facilities. + In-depth knowledge of global regulatory requirements (FDA, EMA, PMDA, etc.) and GxP standards. + ... agency inspections (eg, FDA, EMA, PMDA, etc.) across global pharmaceutical, biotech, cell therapy, and medical device...fields, required. + 10+ years of relevant experience in regulatory affairs , compliance, or quality assurance in… 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
- 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 , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Mitsubishi Tanabe Pharma Group,… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Ensure program success by working cross functionally with R&D-Engineering, Marketing, Medical Affairs , Manufacturing, Quality and Regulatory Affairs . + ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...science and engineering principles + Working experience in medical device industry + Familiar with design control process and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and integration with design control processes. + Collaborate cross-functionally with R&D, Regulatory Affairs , Medical Affairs and Marketing teams to ... 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… 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …risk assessments, method development, and validation activities, supporting compliance with global regulatory requirements and internal quality standards. The ... requires strong collaboration with cross-functional teams, including Platform Product R&D, Regulatory Affairs , and Manufacturing, to deliver safe, effective, and… more