- 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
- 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)
- …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
- 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
- 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
- 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
- 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
- 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)
- …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
- 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
- J&J Family of Companies (Raritan, NJ)
- …products throughout the lifecycle + Connect with respective colleagues in the Clinical TA, Medical Affairs , Global Regulatory Affairs and the QPPV J&J IM ... in dealing with difficult safety issues, clinical safety data, interactions with global regulatory departments / agencies, and strong collaborative and… more
