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Medical Compliance and Regulatory Affairs Manager
2 months ago
Removery LLC is in search of a dedicated Medical Regulatory and Compliance Manager to ensure the utmost standards of medical and regulatory adherence across our various locations. This pivotal role involves providing strategic guidance to our headquarters and field teams, ensuring compliance with local regulations, and enhancing client care and safety.
Key Responsibilities- Regulatory Compliance: Stay informed about regulatory requirements across multiple regions, including the development and implementation of policies to ensure compliance.
- Medical Director Liaison: Collaborate with Medical Directors to ensure they are integrated with their teams and that protocol changes are communicated effectively.
- Clinical Trial Coordination: Manage the IRB approval process and ensure compliance with all protocols.
- Clinical Advisory Board Coordination: Organize CAB meetings, document discussions, and ensure protocol changes are properly recorded.
- Quality Assurance: Contribute to programs aimed at enhancing patient care quality and treatment outcomes.
- Incident Reporting: Analyze clinical and safety incidents to identify trends and collaborate on solutions.
- Clinical Case Review: Report on clinical cases and review trends in side effects.
- Risk Management: Identify potential risks and develop strategies to mitigate them.
- Training and Education: Assist in the development of training programs for medical staff on regulatory changes.
- Audit and Reporting: Conduct audits to assess compliance and prepare reports for leadership.
- Credentialed in healthcare as a nurse, nurse practitioner, or physician assistant.
- A minimum of 5 years of experience in medical regulatory roles with a focus on compliance.
- In-depth knowledge of local regulatory requirements.
- Strong analytical and problem-solving skills.
- Commitment to ethical standards in medical practice.
- Ability to thrive in a dynamic environment.
Removery LLC offers a competitive salary and a comprehensive benefits package, including medical, dental, and vision coverage, paid time off, and a collaborative work environment.
