- Meta (New York, NY)
- …a scientific discipline or equivalent work experience 6. 6+ 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 (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
- 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
- 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. ... turn the impossible into possible for millions. **Our Team/ Overview:** The Global Regulatory Affairs (GRA) CMC & Device Organization serves as a critical… more
- Capgemini (New York, NY)
- …and lessons learned. **Skills & Experience (Required)** + **12 years** in regulatory affairs ; direct leadership of **IND/NDA/BLA/MAA** submissions (10 successful ... **Title:** _Capgemini Invent - Senior / Managing Consultant - Life Sciences, Regulatory Affairs & Quality_ **Location:** _NY-New York_ **Requisition ID:**… 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
- 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