- Xylem (Bridgeport, NJ)
- …+ Responsible for documentation requirements in accordance with other government agencies ( FDA , EPA, DOT). + Work closely with cross-functional teams and other ... to ensure all international trade activities are properly documented and in compliance with all applicable laws and regulations. + Provide training on trade… more
- BeOne Medicines (Pennington, NJ)
- **_General Description:_** Responsible for the design, implementation, and management of Compliance programs for the Hopewell, NJ site. Programs which require ... the job_** **_:_** + Within the Quality Assurance organization, develop and implement Compliance programs for the Hopewell, NJ Site. Ensuring the strategy meets the… more
- United Therapeutics (Trenton, NJ)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... about pharmacovigilance! You are a team player who loves quality, compliance , finding solutions and ensuring training standards are implemented and successful.… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …+ Coordinate, prepare, and complete premarket applications to the US FDA , including Premarket Notification [510(k)], Pre-Sub, and De Novo submissions in ... a timely manner. Act as liaison with FDA regarding product submissions. Experience in Safer Technologies Program (STeP), Breakthrough Device designation, and… more
- Integra LifeSciences (Princeton, NJ)
- …Regulatory, Legal, and Operations to ensure alignment across product lifecycle phases and compliance with medical device regulations (eg, FDA , ISO 13485, MDR). ... procurement, indirect material & capital equipment procurement, services, trade compliance , sourcing & supplier management, analytics, and forecasting. **SUPERVISION… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …regarding customer complaint processing, MDR's, complaint report ability, and regulatory compliance . + Fills out decision trees when needed, after appropriate ... reviews and approves. + Generates MDR reports in accordance with BD procedures and FDA regulations. **To be successful in this role, you should be able to… more
- Terumo Medical Corporation (Somerset, NJ)
- …applications as applicable to SAP software + Some familiarity with SOX and IRM compliance + Some familiarity with FDA CFR Part 11 Software Validation processes ... SAP ECC 6.0, Extended Warehouse Management (EWM), Integration with Global Trade Compliance (GTS) and Transportation Management (TM) is required + SAP Certification… more
- Organon & Co. (Jersey City, NJ)
- …time to approval by regulatory agencies, including but not limited to US- FDA or EU procedures (centralized, mutual recognition, decentralized) + Independently manage ... Represent our company with external organizations through direct communication with the FDA , EMA, or other EU regulatory agencies, including telephone calls and… more
- Ascendis Pharma (Princeton, NJ)
- …Affairs, Advertising and Promotion will be an internal expert on US FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug ... corporate, and other non-promotional materials to assess for regulatory compliance with the applicable regulations, guidance documents, and internal policies/best… more
- RWJBarnabas Health (Long Branch, NJ)
- …governing biomedical research; ensuring that all IRB activities and documents are in compliance with OHRP and FDA regulations + Attends local and national ... and guidelines to protect human subjects and to ensure institutional compliance by providing regulatory, ethical, and methodological advice to investigators, staff,… more