- Meta (New York, NY)
- …a scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. ... regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- Sanofi Group (Morristown, NJ)
- …Sciences or other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs , with 5+ years specifically ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...without relying on authority, including participating in cross-functional groups ( medical , legal, regulatory , etc.) to lead toward… more
- IQVIA (Parsippany, NJ)
- …data, etc.), HCP engagement by life sciences companies. Expertise in domains adjacent to medical affairs , such as regulatory or pharmacovigilance, would also ... **Manager, Medical Affairs Strategy** **Overview** IQVIA is...diverse client base includes the global top 20 pharmaceutical, medical device , and biotechnology companies as well… more
- embecta (Parsippany, NJ)
- …discipline (eg engineering, bioengineering, biology, chemistry). + 5+ years Regulatory Affairs experience in medical device companies. + Must have ... in both the US and Europe, and related regulatory affairs activities to ensure compliance with...current knowledge of the US and European Medical Device regulations. + Demonstrated success in… more
- Sanofi Group (Morristown, NJ)
- …teams + Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part ... **Job title** : Global Regulatory Affairs Device Lead...to internal regulatory processes and procedures for medical devices + Accountable for regulatory… more
- Kelly Services (Bridgewater, NJ)
- …regulatory approvals + Knowledge of pharmaceutical, consumer or medical device industry regulatory affairs discipline throughout the product lifecycle ... ** Regulatory Affairs Specialist Labeling** Kelly(R) Science...+ **SPECIFIC SKILLS** + Knowledge of pharmaceutical, consumer or medical device industry product labeling processes for… more
- J&J Family of Companies (Raritan, NJ)
- … strategies to support new, modified and currently marketed medical devices . This includes the preparation of regulatory documentation for submissions to ... Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory … more
- J&J Family of Companies (Raritan, NJ)
- …coordination, compilation, and submission of investigational and new in vitro diagnostic medical device applications to the regulatory authorities. This ... Medicine R&D is recruiting for an Associate Director, Global Regulatory Affairs Diagnostics. This position is a...global submissions for (new) In Vitro Diagnostics (IVD) and Medical Devices (MD) to Health Authorities (HAs).… more
- Sanofi Group (Morristown, NJ)
- …framework, providing expert guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle. ... we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as… more
- Roche (Branchburg, NJ)
- …of IVDs/ Medical devices /Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent. + You have demonstrated experience and ... with the people we love. That's what makes us Roche. At Roche Global Regulatory Affairs we strive to be the world's best Regulatory organization, championing… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … role within the core team, aiding product development, remediation projects, and meeting medical device regulatory needs. + Review, comprehend, and compose ... devices to align with global regulations. + Support regulatory submissions towards EU MDR requirements, including but not... device or pharmaceutical industry (clinical research or medical affairs ) + Experience in medical… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …a **maker of possible** with us. Reporting directly to the business unit Vice President of Medical Affairs , the Director of Medical Affairs has the ... responsibility to support the VP, Medical Affairs in providing medical , scientific and technical...in clinical investigation and 6 years' experience in the Medical Device /In Vitro Diagnostics or related industry… 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 ... miracles of science to improve people's lives", Specialty Care Medical Affairs have a vision to be...engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs … more
- Organon & Co. (Jersey City, NJ)
- …years of industry experience in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + ... leading the development or life-cycle management of drugs or devices which improve human health. The program manager may...plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical ,… more
- Sanofi Group (Morristown, NJ)
- …strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team...teams. + Contribute to and execute innovative and sustainable medical device regulatory strategies covering… more
- Colgate-Palmolive (New York, NY)
- …+ DDS, DMD, or PhD. + Minimum of 10 years of experience in scientific affairs , medical affairs , or a related scientific role within the pharmaceutical, ... range of oral health needs. The Director of Scientific Affairs for Colgate Oral Pharmaceuticals is a pivotal role... medical device , or consumer healthcare industry. +… more
- Terumo Medical Corporation (Somerset, NJ)
- …product and scientific support for the organization that includes Medical Affairs , Clinical Operations, Sales, Marketing, Regulatory Affairs , to ensure ... therapeutic area, provide support in the following ways: + Medical affairs strategy: + Contribute to the...+ Regulatory activities partnership: + Work with regulatory affairs to ensure that all written… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Bioengineering, Biology, Chemistry). + Minimum of 5 years of Regulatory Affairs experience in medical devices , preferably sterile single-use disposable ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist will represent...Q-Sub), EU technical documentation under MDR, and other global regulatory filings. + Evaluate medical device… more
- Pfizer (New York, NY)
- …industry, preferably in Drug Development or Clinical Research, ideally within Regulatory Affairs + Subject-matter expertise within assigned therapeutic area ... to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Regulatory Affairs more
- Bayer (Whippany, NJ)
- …radiopharmaceuticals as stand-alone and/or theranostic pairs, in a constellation of diagnostic medical device and software assets in the Radiology MI space ... project goals from development through life cycle; + Represents Global Regulatory Affairs on assigned global Project Teams; + Develops submission materials for… more