- Terumo Medical Corporation (Somerset, NJ)
- …stakeholders, to include Clinical Affairs , Professional & Clinical Education, Regulatory Affairs , Quality Systems, Marketing, Sales as well as external ... documents and scientific presentations in cooperation with the Clinical, Medical, & Regulatory Affairs Teams, Key Opinion Leaders and physician investigators. +… 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)
- …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...guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle.… 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
- Sanofi Group (Morristown, NJ)
- …Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global Research and ... Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800... global healthcare industry. + Proven experience in drug/ device combination product regulatory approvals. + Demonstrate… 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
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA...a minimum of 1 year (3+ years preferred) of regulatory experience, preferably within the pharmaceutical/medical device /biotech… 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
- Bristol Myers Squibb (Princeton, NJ)
- …or Madison, New Jersey **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for ... issue resolution, paired with deep expertise in developing and executing global regulatory strategies across drug and device development. + Regulatory … 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
- 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
- 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
- AbbVie (Branchburg, NJ)
- …RDQA) organization, working collaboratively and strategically with colleagues in R&D, Operations, Regulatory Affairs , Medical Safety and more to develop and ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description As a Medical Device & Combination Product Quality Intern at AbbVie, you...ensure the needs of each site are represented in global procedures. We support the development of a variety… more
- Kelly Services (Bridgewater, NJ)
- …+ Participate in company audits, as needed **Requirements:** + Knowledge of medical device industry, regulatory affairs , as well as discipline throughout ... Knowledge of standards and regulations relating to submissions and regulatory approval of device products. + Knowledge...Ability to understand and apply business drivers outside of Regulatory Affairs . + Strong communication skills; both… more
- J&J Family of Companies (Raritan, NJ)
- …maintaining a robust program, and collaborating closely with Quality, Supply Chain, Regulatory Affairs , R&D, and Corporate Compliance partners to support current ... combined or separately, 20+ years of experience in Pharmaceutical or Medical Device Quality Assurance or Quality Operation and/or Regulatory Compliance; or… 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
