- 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
- 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
- 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
- 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
- Bausch Health (Bridgewater, NJ)
- …and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/ ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Sanofi Group (Morristown, NJ)
- …(3+ years preferred) of regulatory experience, preferably within the pharmaceutical/ medical device /biotech industry + Knowledge and understanding of complex ... **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location**...R&D colleagues, as well as other stakeholders (eg, Legal, Medical , Marketing, Communications and Compliance). + Participates in the… more
- Kelly Services (Bridgewater, NJ)
- … Affairs Specialist** Kelly Science and Clinical is seeking a ** Regulatory Affairs Specialist** **for** our client a leading medical device company in ... **Responsibilities** + Provide support for the execution of the pharmaceutical regulatory strategy and submissions for assigned products: Provide support for… more
- Novo Nordisk (Plainsboro, NJ)
- …with Brand teams, other functional teams in NNI (including MAPA), including marketing, medical , R&D, regulatory affairs , finance, NNGlobal, and other ... plan for devices for the brand portfolio (eg, single dose device , PDS290, pre-filled syringe), and maintaining strategic oversight of device -related elements… 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
- Abbott (Princeton, NJ)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... colleagues serve people in more than 160 countries. **Director, Medical Affairs ** **Abbott is a global healthcare leader, creating breakthrough science to… more
- J&J Family of Companies (Raritan, NJ)
- …, biologics, or drugs is strongly preferred. + Experience in support of global regulatory submissions for medical devices , biologics or drugs is desirable ... and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical … 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
- 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
- Bayer (Whippany, NJ)
- …medical research activities; + Working knowledge of US, EU, and international medical device ( regulatory requirements; demonstrated experience with health ... and submissions; + Good knowledge of registration files for Medical Devices and/or In Vitro Diagnostics is...preferred with 10+ years in biomarker/IVD/ regulatory affairs / drug-related development / medical research… more
- Grifols Shared Services North America, Inc (New Brunswick, 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
- Abbott (Princeton, NJ)
- …+ Familiarity and experience working across functions (eg, Operations/Supply Chain, Quality, Regulatory Affairs , Market Access, Medical Affairs , ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....+ Achieve Net Promoter Score and Service Level targets Medical Affairs + Develop a KOL influence… 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