- 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
- 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
- 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
- Novo Nordisk (Plainsboro, NJ)
- …experience; including hands on related pharmaceutical or medical device /pharmaceutical combination product experience and actual regulatory experience + ... About the Department The Clinical, Medical and Regulatory (CMR) department at...agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport… 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
- 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
- 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
- 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
- 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
- Integra LifeSciences (Princeton, NJ)
- …compliant presentation and communication of product information. Reviews all materials with Marketing, Regulatory , Medical Affairs , and legal team to confirm ... + 5+ years of hospital-focused, sales experience within a medical device or pharmaceutical company is required....EQUIPMENT USED Ability to utilize a computer, personal electronic devices , as well as other general office equipment. Strong… 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
- 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
- Sanofi Group (Morristown, NJ)
- …Lead cross-functional teams including digital, senior scientific, technical, finance, commercial, medical , market access, industrial affairs , regulatory and ... team members + Knowledge of the pharmaceutical / biotech / medical device industry(ies), especially R&D Digital and market insights + Multi-country and/or… more
- Novo Nordisk (Plainsboro, NJ)
- …and Engagement, Medical Affairs , Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs , Integrated ... with start-ups, technology companies, and other external partners across diagnostics, medical devices , digital health, digital therapeutics, and data analytics… more
- Danaher Corporation (New York, NY)
- …adoption strategies + Regulatory Knowledge: In-depth understanding of IVD and medical device regulations with strong familiarity of IVD applications in ... Science Liaison (Sr. MSL) will plan and execute the local and regional Medical Affairs (MA) strategies which are aligned and complement the Global MA strategies.… more