- 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
- 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
- Canon USA & Affiliates (Trenton, NJ)
- …including MS Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry required + Minimum Education ... ** Regulatory Affairs Specialist - Post Market...$72,000 to max $116,100 (annual equivalency) **_About us!_** _Canon Medical Systems USA, Inc., a world leader in diagnostic… more
- Bausch + Lomb (Trenton, NJ)
- …Management, Clinical/ Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, Pharmacovigilance/GPSS and Drug/ Device Safety, and Clinical ... in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs… 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
- United Therapeutics (Trenton, NJ)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)**...experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of… more
- Cardinal Health (Trenton, NJ)
- … device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs , Clinical or Regulatory role, preferred + Experience ... and to manage multiple projects simultaneously. Extensive knowledge of the European medical device guidelines/regulations such as MEDDEV and MDD/MDR is required.… 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
- Fujifilm (Trenton, NJ)
- …experts; issues to track may include healthcare policy, biopharmaceutical manufacturing, medical device , tax, trade, export controls, electronic materials, ... affairs with strategic planning for known and potential regulatory activities related to the business and industry areas....working as a lobbyist in life science, pharmaceutical or medical device industry. + Bachelor's degree. (Advanced… more
- Edwards Lifesciences (Trenton, NJ)
- …are at the heart of everything we do. As the Senior Director, THV Medical Affairs , you will drive strategy development, evidence generation initiatives, and ... health economics and outcomes research teams ensuring seamless integration of medical affairs initiatives into broader organizational efforts. + Building… 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …to serve as an clinical/ medical scientific consultant to health economic, medical affairs , marketing, regulatory , statistical and other research project ... medical usefulness and value of drug or medical device product candidates. + Interprets and...medical writing. + Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory … more
- Grifols Shared Services North America, Inc (Freehold, 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
- 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
- Colgate-Palmolive (Piscataway, NJ)
- …customers, including, Product Development, Consumer Affairs , Legal Department, Government Affairs , and Regulatory Affairs . + Representation of Colgate's ... + 0-3 Years of Experience in Product Safety/Toxicology with a consumer products, medical device , food, or pharmaceutical company. + 0-3 years of experience… more
- Novo Nordisk (Plainsboro, NJ)
- …with cross-functional teams, including Field Sales, Marketing, Strategic Partnership and Engagement, Medical Affairs , Market Access and Public Affairs ... (MAPA), Customer Engagement and Integrated Solutions, Commercial Excellence, Legal, Regulatory Affairs , Compliance and other relevant NNI departments to ensure… more
- Integra LifeSciences (Princeton, NJ)
- …and execute plans. + Deep knowledge of global sourcing, contract manufacturing, and regulatory compliance in medical devices . + Strong leadership, ... and Operations to ensure alignment across product lifecycle phases and compliance with medical device regulations (eg, FDA, ISO 13485, MDR). Ensure supplier… more