- Oracle (Trenton, NJ)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- 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. ... **Summary:** We're seeking a regulatory affairs specialist to join our medical ...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- Cardinal Health (Trenton, NJ)
- …in related field or equivalent work experience, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + ... **_What Regulatory Affairs contributes to Cardinal Health_**... and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory … more
- GRAIL (Trenton, NJ)
- …, development, clinical affairs , quality, or program management within the IVD, medical device , or pharmaceutical industries is required. + Regulatory ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals is required.… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for ... Solid scientific background, PhD., MD, PharmD, MS + Significant experience in regulatory affairs and diagnostic-related development eg, >8-10 years. + Scientific… more
- ThermoFisher Scientific (Cranbury, NJ)
- …or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial role in interpreting and ... requirements and desired marketing claims. + Author and/or review regulatory submissions, specifically device master files, ...count on, which includes: + A choice of national medical and dental plans, and a national vision plan,… more
- IQVIA (New York, NY)
- …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
- Fujifilm (Trenton, NJ)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- Veterans Affairs, Veterans Health Administration (East Orange, NJ)
- …directly or through the facility's hardwired and wireless networks. Adheres to Medical Device Isolation Architecture Guidelines in both pre-procurement and ... Commission, National Fire Protection Association, Food and Drug Administration, Nuclear Regulatory Commission, Association for the Advancement of Medical … more
- Mount Sinai Health System (New York, NY)
- …studies + 3+ years of direct experience in Regulatory Affairs , Clinical Affairs or Quality Assurance within the Medical Device Industry Preferred: + ... **Job Description** A Regulatory Compliance Coordinator position is currently available within...medical knowledge preferred. **Responsibilities** + Protocol development: Provides regulatory support to clinical trial project teams. Work with… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Pfizer (New York, NY)
- …communications plans/data dissemination in partnership with the Global, US, and International Medical Content Channel and Medical Affairs teams, integrating ... media solutions that align to the impact the Global Medical Affairs strategy and shape the digital...+ Liaise with Global and US internal stakeholders, including Medical , Regulatory , Digital Readiness Team (DRT), Commercial,… more
- J&J Family of Companies (Titusville, NJ)
- …publications emerging from the Team and its affiliates + Assists Regulatory Affairs in the development of drug/ device regulatory strategies and ... interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality monitoring &… more
- Wolters Kluwer (New York, NY)
- …a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This position is responsible for enabling engineering ... The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic… more
- AbbVie (Jersey City, NJ)
- …toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, ... for safety surveillance for pharmaceutical / biological / drug - device combined products + Lead and set the strategy...for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , ... suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain, and business development functions. TPA… more
- Terumo Medical Corporation (Somerset, NJ)
- …TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide ... and Clinical Training Managers, Sales, Field clinical, Marketing, and Medical Affairs to ensure training curriculum and...3 years of relevant sales training experience in a medical device or pharmaceutical environment or equivalent… more
- Terumo Medical Corporation (Somerset, NJ)
- …TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide ... Date: Dec 18, 2025 Req ID: 5279 Location: Somerset, NJ, US Company: Terumo Medical Corporation Department: Clinical Affairs Terumo Medical Corporation (TMC)… more
- Danaher Corporation (New York, NY)
- …company product teams to execute with supporting organizations (sales, commercial marketing, medical affairs , R&D, manufacturing, regulatory , quality, etc.) ... Finance, R&D, Regulatory Affairs , Clinical Affairs , Sales & Marketing, Corporate Development, Medical ...corporate, global or regional marketing role involving diagnostic or medical device products/services. + Exposure to P&L… more