- 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
- Pentax Medical (Montvale, NJ)
- … and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an established medical ... future of medical technology. Responsibilities of Senior Regulatory Affairs Specialist : + Coordinate with...regulated employer + Thorough understanding of domestic and international regulatory requirements for medical devices … more
- IQVIA (New York, NY)
- …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
- 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)
- …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
- Stryker (Mahwah, NJ)
- **Senior Manager, Regulatory Affairs - Joint Replacement Division** **Location:** Hybrid - Mahwah, NJ As the **Senior Manager, Regulatory Affairs ** , you ... new product launches and patient-specific solutions. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time… 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
- 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 ... requirements and desired marketing claims. + Author and/or review regulatory submissions, specifically device master files, ...count on, which includes: + A choice of national medical and dental plans, and a national vision plan,… 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
- 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
- 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
- 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
- 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
- Veterans Affairs, Veterans Health Administration (Bronx, NY)
- …or radiological devices involving their interfaces and connections to other medical devices or information systems either directly or through the facility's ... hardwired and wireless networks. Adheres to Medical Device Isolation Architecture Guidelines in both...assigned, employee is responsible for lifecycle management of other medical devices and systems such as life… more
- Danaher Corporation (New York, NY)
- …core labs, Define product vision, roadmap, and key requirements in collaboration with R&D, regulatory , medical affairs , and commercial teams + Build and ... 9+ years relevant experience + Product Management experience in diagnostics, biotechnology, medical devices or related fields with hands-on leadership in… 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