- Integra LifeSciences (Plainsboro, NJ)
- …perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other ... applicable regulatory agencies. Expectations are to be familiar with and...Control, preferred. + Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP. + Knowledgeable in Microsoft Office… more
- Integra LifeSciences (Plainsboro, NJ)
- …all established costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the ... to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all assigned employees are aware… more
- Novo Nordisk (Plainsboro, NJ)
- …in other NNI departments, including but not limited to Medical, Regulatory , Marketing, Sales, Commercial Operations, and Ethics, Compliance & Privacy. May ... have been spent working in at least one of the following: + At the FDA + Supporting the pharmaceutical sector + Product liability litigation + Candidates with prior… more
- Penn Medicine (Somers Point, NJ)
- …/ Regulatory + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... + Clinical Care Associates (CCA) MAs - if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- Penn Medicine (Mount Laurel, NJ)
- … Regulatory : + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) ... to emergency/code situations. + CCA MAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- Penn Medicine (Woodbury Heights, NJ)
- …/ Regulatory : + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... to emergency/code situations. + CCA CSAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- Cardinal Health (Trenton, NJ)
- …to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company ... (GPOs, IDNs, hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory /compliance and contract manufacturing. **_Responsibilities_** + Demonstrate strong business… more
- Sanofi Group (Morristown, NJ)
- …strategic business support to maintain Sanofi's commitment to ethical practices and regulatory compliance. We are an innovative global healthcare company with one ... monitoring program across multiple Business Units to ensure compliance with regulatory requirements, internal policies, and product messaging + Maintain robust… more
- Pfizer (Peapack, NJ)
- …contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports ... Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA , EMA, and global regulations. + Strong scientific writing skills and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …advance scientific exchange and product innovation. + Offer clinical expertise for regulatory submissions and communicate with FDA and international authorities ... through commercial launch-ensuring all products meet rigorous safety, efficacy, and regulatory standards. + Clinical Risk Assessment: Collaborate with the Global… more