- Danaher Corporation (Miami, FL)
- …The Regulatory Affairs Intern will gain hands-on experienc e in regulatory strategy, documentation, and compliance within the life sciences industry. You'll ... work alongside experienced professionals to support regulatory submissions and ensure alignment with global standards. This.... Collaborate with cross-functional teams including R&D, Quality, and Clinical Affairs . Help ensure compliance with… more
- Gilead Sciences, Inc. (Washington, DC)
- … regulatory initiatives focused on combination products and devices. Ensure regulatory conformance and consistency across markets, maintaining compliance with ... regulatory filings. Provide leadership for agency interactions, inspections, and regulatory responses. Ensure readiness and compliance for global… more
- GE HealthCare (Chicago, IL)
- … requirements for product launch, premarket submissions/registrations and post-market compliance , working closely with healthcare regulatory bodies globally. ... requirements for product launch, premarket submissions/registrations and post-market compliance , working closely with healthcare regulatory bodies globally.… more
- Dartmouth Health (Bennington, VT)
- …Quality & Regulatory Accreditation. The position provides leadership of regulatory compliance including varied program accreditations and patient safety. ... and resource to program staff members.The position provides leadership of regulatory compliance including varied program accreditations and patient safety.… more
- Mount Sinai Health System (New York, NY)
- …2 years managing investigator-initiated trials preferred. + Proven track record in regulatory compliance , project management, and team leadership. + Progressive ... Prioritize resources and allocate tasks to ensure timelines and objectives are met. ** Regulatory Compliance and Quality Assurance:** + Ensure all trials adhere… more
- UPMC (Pittsburgh, PA)
- …to regulatory readiness, Department of Health investigations, Joint Commission compliance , and assist with complaint and grievance investigations, as well as ... Specialist, Patient Relations team, and the Privacy and Compliance Officer to support a Just Culture through risk...clinical experience OR experience in patient safety and regulatory or a combination of both is required. +… more
- Merck (Augusta, ME)
- …and proactively and result in outcomes that demonstrate the Company's dedication to regulatory compliance . + Ensures that a cross-functional team (eg Quality & ... ICH GCP Guidelines, Management Process, Medical Writing, Process Improvements, Regulatory Compliance , Risk Management, Social Collaboration, Strategic Planning,… more
- Actalent (Remote, OR)
- …Trial Registry + Study Start-Up + Clinical Trial Disclosure + Clinical Research + Regulatory Affairs + Regulatory Compliance + EU CTR + US FDA + ICH ... biological science field required. + 1-3 years of experience in clinical trial registries, regulatory agency transparency, or drug development with a clinical… more
- Stryker (San Jose, CA)
- …be provided. **Key Areas of Responsibility:** + Ensure divisional achievement of quality, regulatory , and compliance targets + Direct activities to ensure new ... a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory , and compliance targets + Demonstrated ability to… more
- Insight Global (Rochester, MN)
- … Regulatory Affairs. The contractor will focus on the execution of regulatory documentation, submissions, and compliance tasks to ensure timely delivery of ... timelines, and status reports for leadership. - Collaborate with Quality, Regulatory , Clinical , and Engineering teams on project-specific regulatory … more