- 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
- 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
- Pentax Medical (Montvale, NJ)
- … and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an established medical ... future of medical technology. Responsibilities of Senior Regulatory Affairs Specialist : + Coordinate with...regulated employer + Thorough understanding of domestic and international regulatory requirements for medical devices … more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …field. Advanced degree preferred. + Minimum of 5 years Regulatory Affairs experience in medical devices , preferably sterile single-use disposable ... **Job Description Summary** The Staff RA Specialist will represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform on… 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
- 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
- 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
- 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …a **maker of possible** with us. Reporting directly to the business unit Vice President of Medical Affairs , the Director of Medical Affairs has the ... responsibility to support the VP, Medical Affairs in providing medical , scientific and technical...NJ** + Minimum of 10 years' experience in the Medical Device /In Vitro Diagnostics or related industry… 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
- 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
- Sanofi Group (Morristown, NJ)
- …strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team...cross-functional teams + Develop and execute innovative and sustainable medical device regulatory strategies covering… more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... team is part of the Global Regulatory Affairs , Regulatory CMC and Device ...to internal regulatory processes and procedures for medical devices and combination products. + Engage… more
- Sanofi Group (Morristown, NJ)
- …strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team...teams. + Contribute to and execute innovative and sustainable medical device regulatory strategies covering… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …creation, and integration with design control processes. + Collaborate cross-functionally with R&D, Regulatory Affairs , Medical Affairs and Marketing ... ongoing maintenance and improvement of product risk files for medical devices . This role is responsible for...relevant experience **Skills:** + Extensive knowledge of the FDA medical device quality system regulations and international… 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
- Pfizer (New York, NY)
- …You Will Achieve** You will represent Pfizer as an approval liaison in the regulatory affairs team assisting with diagnostics regulatory tasks. You will ... to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Regulatory Affairs more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …+ Ensure program success by working cross functionally with R&D-Engineering, Marketing, Medical Affairs , Manufacturing, Quality and Regulatory Affairs ... knowledge of material science and engineering principles + Working experience in medical device industry + Familiar with design control process and medical … more
