- Meta (New York, NY)
- …the combination of AI with great form factors can do. We are seeking an experienced medical devices regulatory affairs professional to help us execute ... products with distribution into many worldwide markets. **Required Skills:** Medical Devices Regulatory Affairs...Medical Device Directive & European Union Medical Device Regulation, FDA regulatory … more
- Stryker (Mahwah, NJ)
- …3+ years of experience in an FDA regulated industry + 2+ years of experience in medical device regulatory affairs + Thorough understanding of FDA, ... Europe, and international medical device regulations + Experience drafting regulatory submissions... Affairs ) + Previous experience with Class II/III medical devices + Previous experience drafting 510(k)s… more
- Sanofi Group (Morristown, NJ)
- …responsibilities. **About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...+ Dealt effectively with cross-functional groups, which may include Medical , Legal, Marketing, etc. + Experience managing others is… more
- Belcan (Whippany, NJ)
- …accurate content for external and internal use. * Collaborate with cross-functional teams including Medical Affairs , Regulatory , and Legal to review and help ... Senior Manager, Medical Affairs Communications - Oncology Job...* 1-2 years of experience in the pharmaceutical or medical device industry * Prior experience in… more
- 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … Professional Society (RAPS) certification preferred + 4 years Regulatory Affairs experience in the medical device industry preferred **Knowledge ... Specialist independently supports projects to bring new and modified medical devices to market and ensure ongoing...design control documents and product labeling, and evaluate proposed device changes. The Sr. Regulatory Affairs… more
- Merck (Rahway, NJ)
- **Job Description** Position Description: The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global ... Regulatory Affairs and Clinical Safety (GRACS) function...including drug device /combination products and software as medical device platforms. Reviews and resolves issues… more
- Stryker (Mahwah, NJ)
- …of managerial/supervisory experience + Understanding of global medical device regulations including direct experience with regulatory submissions associated ... We are currently seeking a **Senior Manager, Regulatory Affairs ** to join our Joint...with US and EU Class II/III medical devices + Ability to lead a… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Associate Director, Regulatory Affairs , Specimen Management (SM) reports directly to the Vice President, Regulatory ... drive success, and leading and inspiring a team of regulatory affairs associates. This role will directly...+ At least 10 years of experience in the IVD/ medical device field with growing responsibility. +… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Advanced degree preferred; medical training preferred. + Minimum 8 years of regulatory affairs experience within the pharmaceutical or medical device ... **Job Description Summary** As Regulatory Affairs Associate Director, you will...strong and respected voice. + Comprehensive knowledge of US medical device regulations (FDA), Clinical Practice standards,… 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...investigation + Minimum of 10 years experience in the Medical Device /In Vitro Diagnostics industry required. More… more
- Wolters Kluwer (New York, NY)
- …portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important ... software launches and market expansions. **Post-Market Surveillance and Regulatory Affairs ** + Coordinate post-market activities including... regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP.… more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... team is part of the Global Regulatory Affairs , Regulatory CMC and Device ...to internal regulatory processes and procedures for medical devices and combination products. + Engage… 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …**maker** **of possible** with us. **About the role:** Reporting to the VP of Medical Affairs , the Associate Director provides strategic medical , scientific, ... in infection control highly preferred + Minimum of 7 years' experience in the Medical Device /In Vitro Diagnostics industry required. + Minimum of 4 years of… more
- Haleon (Warren, NJ)
- …+ Additional experience of product safety related disciplines (eg, clinical development, medical affairs , regulatory ) preferred. + Professional qualification ... has a large portfolio of products including medicines, cosmetics, medical devices and dietary supplements. In line...defects at manufacturing sites. + Provide safety expertise into regulatory documents and responses to boards of health. +… more
- Veterans Affairs, Veterans Health Administration (East Orange, NJ)
- …therapy and brachytherapy. The TMP develops, operates and fully documents the medical physics quality assurance program and ensures regulatory compliance within ... therapy, and brachytherapy. The TMP develops, operates and fully documents the medical physics quality assurance program and ensures regulatory compliance within… more
- Grifols Shared Services North America, Inc (Newark, NJ)
- …regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides ... staff + May have responsibility for maintaining a compliant medical device quality system for R&D and...years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the… more
- Edwards Lifesciences (Newark, NJ)
- …+ Knowledge and understanding of cardiovascular science + Moderate understanding of medical device regulatory requirements and documents, device ... (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) or related medical device , clinical, or Certification in RDCS (Registered Diagnostic… more
- Sanofi Group (Morristown, NJ)
- …to and/or lead cross-functional teams including senior scientific, technical, finance, commercial, medical , market access, industrial affairs , regulatory and ... commercial team members + Knowledge of the pharmaceutical / biotech / medical device industry(ies), especially product development and/or commercialization +… more