- 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
- Sanofi Group (Morristown, NJ)
- …Sciences or other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs , with 5+ years specifically ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...without relying on authority, including participating in cross-functional groups ( medical , legal, regulatory , etc.) to lead toward… more
- Terumo Medical Corporation (Somerset, NJ)
- …assigned clinical reports, documents and scientific presentations in cooperation with the Clinical, Medical , & Regulatory Affairs Teams, Key Opinion Leaders ... include Clinical Affairs , Professional & Clinical Education, Regulatory Affairs , Quality Systems, Marketing, Sales as...a medical writer for pharmaceutical, CRO, or medical device clients, a strong plus. **Nearest… 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
- embecta (Parsippany, NJ)
- …discipline (eg engineering, bioengineering, biology, chemistry). + 5+ years Regulatory Affairs experience in medical device companies. + Must have ... in both the US and Europe, and related regulatory affairs activities to ensure compliance with...current knowledge of the US and European Medical Device regulations. + Demonstrated success in… more
- Bayer (Whippany, NJ)
- …As the Director of Regulatory Affairs , you will represent our medical device regulatory team within the Molecular Imaging platform. This pivotal ... required + Direct professional experience in Regulatory Affairs within the medical device ... device industry, with significant experience involving medical devices pumping systems, or software-driven electromechanical… more
- Sanofi Group (Morristown, NJ)
- …teams + Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part ... **Job title** : Global Regulatory Affairs Device Lead...to internal regulatory processes and procedures for medical devices + Accountable for regulatory… more
- J&J Family of Companies (Raritan, NJ)
- …health authorities concerning clinical/ medical issues + Assists Regulatory Affairs in the development of drug/ device regulatory strategies + ... via matrix interactions also includes individuals from project management, operations, regulatory affairs , data management, medical writing, biostatistics,… more
- J&J Family of Companies (Raritan, NJ)
- …for products throughout the lifecycle + Connect with respective colleagues in the Clinical TA, Medical Affairs , Global Regulatory Affairs and the QPPV ... responsible for the oversight of deliverables and the strategic direction of the Medical Safety Officers (MSO) and Safety Analysis Scientist TA Lead (SAS TAL) within… more
- J&J Family of Companies (Raritan, NJ)
- …coordination, compilation, and submission of investigational and new in vitro diagnostic medical device applications to the regulatory authorities. This ... Medicine R&D is recruiting for an Associate Director, Global Regulatory Affairs Diagnostics. This position is a...global submissions for (new) In Vitro Diagnostics (IVD) and Medical Devices (MD) to Health Authorities (HAs).… more
- Kelly Services (Bridgewater, NJ)
- …Participate in company audits, as needed **Requirements:** + Knowledge of medical device industry, regulatory affairs , as well as discipline throughout ... Lead is responsible for leading labeling artwork development/ revisions projects for medical device products, and assessing changes in standards, regulations,… more
- Sanofi Group (Morristown, NJ)
- …framework, providing expert guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle. ... we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as… more
- Bristol Myers Squibb (Princeton, NJ)
- …or Madison, New Jersey **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and ... background, PhD., MD, PharmD, MS **Experience Requirements:** Significant experience in regulatory affairs and diagnostic-related development eg, >8-10 years.… 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
- embecta (Parsippany, NJ)
- …changes, internal audits, or process improvements. + Ensure documentation adheres to global medical device regulatory requirements, including FDA 21 CFR Part ... workflows to enhance efficiency and compliance. + Collaborate with Quality, Manufacturing, Marketing, Medical Affairs , R&D, and Regulatory Affairs teams… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Medical Affairs Director - Oncology **Location:** Cambridge, MA / Morristown, NJ **About the job** **About us:** In order to pursue ... miracles of science to improve people's lives", Specialty Care Medical Affairs have a vision to be...engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs … more
- Stryker (New York, NY)
- …of RWE studies in close collaboration with internal stakeholders from Clinical Strategy, Medical Affairs , Regulatory , HEOR, and Commercial + Ensure ... and/or other health data partners to identifyadditionalreal-world data sources for medical device evidence generation. + Ensure quality and performance… 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
- Colgate-Palmolive (New York, NY)
- …+ DDS, DMD, or PhD. + Minimum of 10 years of experience in scientific affairs , medical affairs , or a related scientific role within the pharmaceutical, ... range of oral health needs. The Director of Scientific Affairs for Colgate Oral Pharmaceuticals is a pivotal role... medical device , or consumer healthcare industry. +… more
- Novo Nordisk (Plainsboro, NJ)
- …closely with cross-functional teams, including sales, marketing, medical affairs , market access and policy/advocacy (MAPA), regulatory affairs ... Nordisk's Rare Disease portfolio. The Rare Disease portfolio includes medical treatments, customer solutions, and devices across...drive market share and revenue growth. Partner with legal, regulatory , and medical affairs for… more