- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Kelly Services (Bridgewater, NJ)
- …+ Participate in company audits, as needed **Requirements:** + Knowledge of medical device industry, regulatory affairs , as well as discipline throughout ... Knowledge of standards and regulations relating to submissions and regulatory approval of device products. + Knowledge...Ability to understand and apply business drivers outside of Regulatory Affairs . + Strong communication skills; both… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …510(k), Q-Sub), EU technical documentation under MDR, and other global regulatory filings. + Evaluate medical device regulations and lead the development ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist will represent...change control, ensuring compliance with US, EU, and other global regulatory requirements. + Author FDA submissions… more
- J&J Family of Companies (Titusville, NJ)
- …via matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality ... for the preparation and approval of essential documents for global regulatory filings. The CL will manage...Team and its affiliates + Assists Regulatory Affairs in the development of drug/ device … more
- J&J Family of Companies (Raritan, NJ)
- …within the medical device industry and with clinical evaluation report regulatory requirements **required** ; thorough understanding of global medical ... Market Surveillance, Clinical Affairs , Design Quality Engineers, R&D, and Regulatory Affairs relating to literature search and systematic review processes.… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Validation &** **Human Factors strategies** for successful submission in concert with Regulatory Affairs . + Conduct **gap analyses** of existing DVal/HF ... **use-related risk analysis (URRA)** and mitigation strategies in partnership with Medical & Regulatory Affairs . + Collaborate with ** Regulatory Affairs… more
- J&J Family of Companies (Raritan, NJ)
- …for worldwide health authorities concerning clinical/medical issues + Assists Regulatory Affairs in the development of drug/ device regulatory strategies ... matrix interactions also includes individuals from project management, operations, regulatory affairs , data management, medical writing, biostatistics,… more
- Bristol Myers Squibb (Madison, NJ)
- …in pharmaceutical (medical device , biologics) facilities. + In-depth knowledge of global regulatory requirements (FDA, EMA, PMDA, etc.) and GxP standards. + ... agency inspections (eg, FDA, EMA, PMDA, etc.) across global pharmaceutical, biotech, cell therapy, and medical device...fields, required. + 10+ years of relevant experience in regulatory affairs , compliance, or quality assurance in… more
- embecta (Parsippany, NJ)
- … changes, internal audits, or process improvements. + Ensure documentation adheres to global medical device regulatory requirements, including FDA 21 CFR ... to enhance efficiency and compliance. + Collaborate with Quality, Manufacturing, Marketing, Medical Affairs , R&D, and Regulatory Affairs teams to ensure… more
- J&J Family of Companies (Raritan, NJ)
- …products throughout the lifecycle + Connect with respective colleagues in the Clinical TA, Medical Affairs , Global Regulatory Affairs and the QPPV J&J IM ... in dealing with difficult safety issues, clinical safety data, interactions with global regulatory departments / agencies, and strong collaborative and… more