- 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
- Takeda Pharmaceuticals (Boston, MA)
- …product strategy across Takeda's development technology portfolio, encompassing Clinical Development, Regulatory Affairs, and Pharmacovigilance domains. ... R&D technology or digital product leadership roles, with deep expertise across Clinical , Regulatory , and Pharmacovigilance domains. + Strong understanding of… more
- Envista Holdings Corporation (Brea, CA)
- …designing and enhancing quality management systems to facilitate overall regulatory compliance . + Responsible for authoring department standard operating ... Technical files and final review of deliverables for MDR regulatory compliance with the goal of achieving...Ormco Ormco is a global leader and innovator of high- quality orthodontic products and solutions, including brackets and wires.… 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
- Hologic (Newark, DE)
- …renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance . Monitors and ... trials applications. The position has primary responsibility for compliance with US, EU and Canadian regulatory ...limited to Regulatory Affairs, Research and Development, Clinical , Quality , and Marketing. Works on complex… 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
- BJC HealthCare (St. Louis, MO)
- …Opportunity in Healthcare Leadership! Consider stepping into the role of Supervisor of Clinical Documentation and Quality within our ACO value-based care team. ... their diverse patient populations. **Preferred Qualifications** **Role Purpose** The Clinical Documentation & Quality Supervisor provides day-to-day leadership… 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
- UCLA Health (Los Angeles, CA)
- …evaluation clinical practices, identifying areas for improvement, and implementing quality improvement initiatives to enhance patient care and safety. In this ... regulatory audits for medical appropriateness by using established clinical protocols and health plan resource tools + Assess...+ Provide education and training to internal staff on quality management practices and regulatory requirements +… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …notifications are required. + Ensure SaMD compliance with FDA guidance on Clinical Decision Support (CDS) software and other regulatory frameworks. + Work ... role involves developing and implementing practices for SaMD devices to ensure regulatory compliance , expedition of product clearances and maintain the highest… more