- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance . + Coordinate and respond to requests for product ... Represent BD in relevant external trade organizations and lead/participate in regulatory standards development/ compliance activities as necessary to support BD's… more
- Abbott (Plymouth, MN)
- …requirements and timelines to project teams. + Evaluate proposed preclinical, clinical , design and manufacturing changes for regulatory submission strategies. ... + 2-3 years' experience in a regulated industry (eg, medical products, nutritional). Regulatory area is preferred but may consider quality assurance, research… more
- Sutter Health (Sacramento, CA)
- …evaluating processes for outcomes management, performance improvement, patient safety and regulatory compliance . Develops and coordinates components of the ... Sutter Health's Clinical Effectiveness and Performance Improvement (PI) Program. Facilitates ...on performance improvement methodologies and evidence-based patient safety and quality initiatives. Provides all levels of management, physicians, and… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules.Ensure ... alignment with regulatory trends, innovation, and compliance while balancing...(eg, BLA, MAA). Identify required documentation and ensure timely, high- quality submissions meeting global requirements. + Health Authority Interactions… more
- Abbott (Alameda, CA)
- …regulatory submission. + Write and edit technical documents. + Administer/meet regulatory requirements to achieve excellent compliance status with no ... regulatory requirements for medical devices, drugs and/or biologics including Quality Systems standards, clinical investigations, ICH guidelines. + Experience… more
- University of Utah (Salt Lake City, UT)
- …compliance with governing requirements. **Responsibilities** Supports all aspects of regulatory compliance . Prepares regulatory documents, including ... regulatory documents to ensure ...study closure activities. Assists investigators and others involved in clinical research with process and policy issues and provides… more
- Insight Global (Rochester, MN)
- … regulatory timelines, and status reports for leadership. - Collaborate with Quality , Regulatory , Clinical , and Engineering teams on project-specific ... Regulatory Specialist to support the Vice President of Quality Assurance and Regulatory Affairs. The contractor...Affairs. The contractor will focus on the execution of regulatory documentation, submissions, and compliance tasks to… more
- Medtronic (Irvine, CA)
- …in sustaining the current product portfolio. The Sr Specialist has responsibility for compliance with US and EU regulatory requirements and partners with the ... tasks to meet project schedules. + Interface with engineering, quality , clinical , marketing, and other functions as...in internal and external audits as needed. + Maintain regulatory affairs documentation to support compliance with… more
- Abbott (St. Paul, MN)
- …be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigations. + Experience with word ... female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist** to join Abbott's Vascular Division on-site in St.… more
- Abbott (Plymouth, MN)
- …for product release. + Conducts reviews of product and manufacturing changes for compliance with applicable commercial and clinical regulations. + Supports all ... their lives. **The Opportunity** Abbott is seeking a passionate, experienced **Senior Regulatory Affairs Specialist** to join our team on-site in Plymouth, MN. In… more