- 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
- 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
- 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
- Meta (New York, NY)
- …discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. Experience working ... **Summary:** We're seeking a regulatory affairs specialist to join our...to work on wearables and Software as a Medical Device (SaMD) applications for the US and worldwide approvals.You… 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 (New York, NY)
- **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
- Colgate-Palmolive (New York, NY)
- …York, New York, United States **Who We Are** Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral ... that address a wide range of oral health needs. The Director of Scientific Affairs for Colgate Oral Pharmaceuticals is a pivotal role responsible for leading and… more
- Pfizer (New York, NY)
- **JOB SUMMARY** Global Regulatory Sciences (GRS) serves as strategic leader and catalyst enabling high quality, efficient, innovative, label-focused global ... within the assigned portfolio, and other disease areas as relevant including ensuring global regulatory strategies for all projects and products within the… 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
- 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
- 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
- Cordis (New York, NY)
- …of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart ... treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR,… more
