- 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
- Haleon (Warren, NJ)
- …legislation covering pharmaceuticals, medical devices , cosmetics and foods. The Regulatory Affairs team helps to guide our company on our responsibility ... us achieve this goal. Right now, we're looking for a Co-Op student in US Regulatory Affairs to join us to do career defining work. **A career in Regulatory … more
- Abbott (Princeton, NJ)
- …75%. **Required Qualifications** + Minimum of 6-10 years of clinical/ medical affairs experience, preferably in medical device industry. + Understanding ... scientific, statistical, regulatory and compliance requirements of clinical research. + Medical Information, Regulatory Affairs , and/or Medical … 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
- AbbVie (Branchburg, NJ)
- …RDQA) organization, working collaboratively and strategically with colleagues in R&D, Operations, Regulatory Affairs , Medical Safety and more to develop ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description As a Medical Device & Combination Product Quality Intern...procedures. We support the development of a variety of medical devices in the Aesthetics space, including… more
- Kelly Services (Raritan, NJ)
- …Supports creation of project value propositions as needed. + Provides strong connectivity with Medical Affairs , R&D, Regulatory Affairs , and Clinical ... communication skills across different organization levels **Preferred:** + Prior experience in medical devices or other regulated industry + Knowledge of… 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
- 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
- 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
- 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
- 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
- Sanofi Group (Morristown, NJ)
- …(3+ years preferred) of regulatory experience, preferably within the pharmaceutical/ medical device /biotech industry + Knowledge and understanding of complex ... **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location**...R&D colleagues, as well as other stakeholders (eg, Legal, Medical , Marketing, Communications and Compliance). + Participates in the… 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
- 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
- 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
- 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
- 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