- 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. ... 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
- 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_**...Brand, Presource, and Sustainable Technologies businesses and range of medical devices . + Maintain 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
- 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
- Kelly Services (Bridgewater, NJ)
- …regulatory approvals + Knowledge of pharmaceutical, consumer or medical device industry regulatory affairs discipline throughout the product lifecycle ... ** Regulatory Affairs Specialist Labeling** Kelly(R) Science...+ **SPECIFIC SKILLS** + Knowledge of pharmaceutical, consumer or medical device industry product labeling processes for… 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
- 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
- Roche (Branchburg, NJ)
- …of IVDs/ Medical devices /Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent. + You have demonstrated experience and ... with the people we love. That's what makes us Roche. At Roche Global Regulatory Affairs we strive to be the world's best Regulatory organization, championing… more
- Capgemini (New York, NY)
- …and lessons learned. **Skills & Experience (Required)** + **12 years** in regulatory affairs ; direct leadership of **IND/NDA/BLA/MAA** submissions (10 successful ... **Title:** _Capgemini Invent - Senior / Managing Consultant - Life Sciences, Regulatory Affairs & Quality_ **Location:** _NY-New York_ **Requisition ID:**… 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
- Parexel (Trenton, NJ)
- …markets? Parexel is seeking an experienced and highly motivated **Global Regulatory Labeling Lead** to provide strategic leadership and operational oversight for ... This role is integral to the development, governance, and maintenance of regulatory labeling content that supports the safe and effective use of products… more
- Fujifilm (Trenton, NJ)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... The Senior Counsel, reporting to the Division General Counsel, Medical Devices , will be an experienced commercial...Counsel and senior business management on general legal and regulatory risks affecting the Medical Device… more
- Danaher Corporation (New York, NY)
- …core labs, Define product vision, roadmap, and key requirements in collaboration with R&D, regulatory , medical affairs , and commercial teams + Build and ... 9+ years relevant experience + Product Management experience in diagnostics, biotechnology, medical devices or related fields with hands-on leadership in… 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
- 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
- Danaher Corporation (New York, NY)
- … regulatory , market access, and post-market). You'll collaborate with clinical, regulatory /quality, R&D, medical affairs , IT/security, and our Operating ... and visualization tools. + Proven experience analyzing RWE/RWD (EHR, claims, registries, device logs) for clinical, regulatory , or market access impact. Travel,… more
- Abbott (Princeton, NJ)
- …**Familiarity and experience working across functions (eg, Operations/Supply Chain, Quality, Regulatory Affairs , Market Access, Medical Affairs ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… 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