- 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
- Oracle (Trenton, NJ)
- …success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration ... across global markets that impact to our businesses, regulatory affairs function, and quality/compliance programs. **Responsibilities** **Preferred… 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing ... variations) around small molecule drug substance, drug products and drug- device combination products. Ensure compliance with global ...local and/or global functional units [OPC CMC Global Regulatory Affairs , Global… more
- GRAIL (Trenton, NJ)
- …with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For...IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device … more
- Stryker (Mahwah, NJ)
- …launches and patient-specific solutions. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time zones ... **Senior Manager, Regulatory Affairs - Joint Replacement Division**...provide leadership and coordination of the Joint Replacement divisions' global regulatory strategies, submission preparation and approvals… 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
- Parexel (Trenton, NJ)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... device combination products are a plus) * Support regulatory leads in developing contingency plans for CMC-related scenarios... Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global … more
- Cardinal Health (Trenton, NJ)
- …field or equivalent work experience, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + Certification in ... **_What Regulatory Affairs contributes to Cardinal Health_**...medical devices + Supports all pertinent activities to ensure global product and regulatory requirements are accounted… more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy ... background, PhD., MD, PharmD, MS + Significant experience in regulatory affairs and diagnostic-related development eg, >8-10...deep expertise in developing and executing global regulatory strategies across drug and device development.… 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
- ThermoFisher Scientific (Cranbury, NJ)
- …or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial role in interpreting and ... Day in the Life:** + Interpret and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical… 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… 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