- Bausch Health (Bothell, WA)
- …changes. Risk Management and Reporting + Conduct risk assessments related to regulatory compliance , helping the company identify potential non- compliance ... affairs team and other departments, such as R&D, clinical , quality assurance, manufacturing, and marketing, to...highlighting regulatory achievements and potential risks. Global Regulatory Compliance + Ensure compliance … more
- BJC HealthCare (St. Louis, MO)
- …their diverse patient populations. **Preferred Qualifications** **Role Purpose** The Clinical Documentation & Quality Supervisor provides day-to-day leadership ... for the clinical documentation and quality team. This position manages team functions and departmental processes, as well as existing clinical measurement… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …procedures; applying best practices; and collaborating with cross-functional teams (eg, R&D, Quality , Clinical Operations, etc.) within the business units to ... ensuring compliance with global requirements applicable standards + Maintain regulatory intelligence and execute regulatory plans, and ensure internal… more
- ThermoFisher Scientific (Austin, TX)
- …Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. You ... coordinating global regulatory strategies on assigned (Phase 1 to 4) clinical trials, studies and projects and providing the technical/ project leadership across… more
- Abbott (Santa Clara, CA)
- …based upon regulatory changes + Support pre and post approval clinical strategy and submission activities + Anticipate regulatory obstacles and emerging ... regulatory and related teams + Assess the acceptability of development, quality , preclinical and clinical documentation for submission filing. Compile,… more
- Abbott (Santa Clara, CA)
- …approval requirements. + Participate in risk-benefit analysis for regulatory compliance . **Premarket:** + Assess the acceptability of quality , preclinical ... review. + Monitor and submit applicable reports to regulatory authorities. + Evaluate proposed preclinical, clinical ...years of experience. + 2-3 years of experience in regulatory preferred but may consider quality assurance,… more
- Philips (Chicago, IL)
- …communications, clinical protocols, design processes, and manufacturing procedures to maintain regulatory and quality compliance . + Drive improvements in ... acquired 7+ years of experience with SaMD/SiMD in areas such as Regulatory Affairs, Quality Compliance , Product Development, etc. in Medical Devices Industry… more
- Globus Medical, Inc. (Audubon, PA)
- …renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance . Monitors and ... we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the… more
- GRAIL (Menlo Park, CA)
- …**Preferred Requirements:** + **Experience** + Minimum of 10 years of experience in regulatory , development, clinical affairs, quality , or program management ... Quality , Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market… more
- Atlantic Health System (Morristown, NJ)
- …and ambulance agreements, and home health and hospice agreements, assuring legal and regulatory compliance . Serve as a primary resource for the interpretation of ... on regulatory issues, including fraud and abuse issues, HIPAA compliance , EMTALA, Medicare and Medicaid compliance , licensure issues, pay-to-play issues,… more