- 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
- 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
- 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
- Terumo Medical Corporation (Somerset, NJ)
- …product and scientific support for the organization that includes Medical Affairs , Clinical Operations, Sales, Marketing, Regulatory Affairs , to ensure ... therapeutic area, provide support in the following ways: + Medical affairs strategy: + Contribute to the...+ Regulatory activities partnership: + Work with regulatory affairs to ensure that all written… 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
- Terumo Medical Corporation (Somerset, NJ)
- …(TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for ... Req ID: 5279 Location: Somerset, NJ, US Company: Terumo Medical Corporation Department: Clinical Affairs Terumo ...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- Terumo Medical Corporation (Somerset, NJ)
- …(TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for ... of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in...and Clinical Training Managers, Sales, Field clinical, Marketing, and Medical Affairs to ensure training curriculum and… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of...Manufacturing and Controls (CMC), medical affairs and business development are critical… 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
- IQVIA (Parsippany, NJ)
- …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
- 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
- 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and develop **use-related risk analysis (URRA)** and mitigation strategies in partnership with Medical & Regulatory Affairs . + Collaborate with ** ... Validation &** **Human Factors strategies** for successful submission in concert with Regulatory Affairs . + Conduct **gap analyses** of existing DVal/HF… 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
