- Integra LifeSciences (Princeton, NJ)
- …Reports, 30 Day Notices, and 180 Day Submissions in accordance with US FDA requirements. + Interact with Regulatory Body personnel with minimal supervision. ... complex Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval… more
- GRAIL (Trenton, NJ)
- …Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and ... Quality , Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market… more
- Parexel (Trenton, NJ)
- …the world, ensuring innovative products are supported by clear, compliant, and high- quality documentation that enables safe and effective use across global markets? ... Parexel is seeking an experienced and highly motivated **Global Regulatory Labeling Lead** to provide strategic leadership and operational oversight for complex… more
- embecta (Parsippany, NJ)
- …International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, ISO 14971, EU MDR, ... patient safety forproducts outside of embecta's control. Provides support to Post-Market Quality ( Regulatory ) partners in execution of applicable field action… more
- Integra LifeSciences (Princeton, NJ)
- …for conformance with EU regulations for CE-marked medical devices. + Experience working for regulatory agencies (such as US FDA , MHRA, TGA, Health Canada, SFDA, ... manufacturing facility engineering and design, statistical analysis, process validation, regulatory compliance, clinical trials, computer systems validation, quality… more
- Integra LifeSciences (Plainsboro, NJ)
- …Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements. + Participate in FDA inspections, ISO ... and set new standards of care. The **Sr. Q** **uality Engineer / Quality Operations (Validations, Risk Management & Statistics)** will provide Plant Quality … more
- Integra LifeSciences (Plainsboro, NJ)
- …pathways to advance patient outcomes and set new standards of care. The ** Quality Inspector II** will be responsible for performing quality assurance inspections ... on purchased components, manufactured sub-assemblies and final product. The Quality Inspector will perform all duties in accordance to the requirements of overall… more
- Integra LifeSciences (Plainsboro, NJ)
- …using electronic document storage. + Minimum of 5+ years' experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably ... 13485, the medical device directive, and the other applicable regulatory agencies. **This is for a Weekend Lead, the...the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality … more
- BeOne Medicines (Pennington, NJ)
- **General Description:** Manages all Quality Control (QC) Physicochemistry laboratory activities to support GMP manufacturing, testing and release of materials, ... intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …external inspections, and corporate audits. Responsible for follow-up on operational findings from FDA and other regulatory bodies. + Participate in and conduct ... products. Supported by more than 40 manufacturing facilities, we provide high- quality medicines, trusted by healthcare professionals and patients, to more than… more
