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Manager of Medical Compliance and Regulatory Affairs
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 operations in multiple countries. This pivotal role will provide strategic guidance to both our headquarters and field teams, ensuring compliance with local regulations while enhancing client care and safety.
Key Responsibilities- Regulatory Compliance: Stay informed on regulatory mandates across Australia, Canada, and the United States; formulate and implement policies to guarantee compliance across all facilities.
- Medical Director Liaison: Collaborate with Medical Directors to ensure their engagement with teams and facilitate regular meetings.
- Clinical Trial Coordination: Manage the IRB approval process and ensure all participant documentation is accurate and compliant with protocols.
- Clinical Advisory Board Coordination: Organize CAB meetings, document proceedings, and ensure protocol changes are communicated effectively.
- Quality Assurance: Contribute to quality assurance initiatives aimed at enhancing patient care and treatment outcomes.
- Incident Reporting: Monitor clinical and safety incidents, analyze data trends, and collaborate on preventive measures.
- Clinical Case Review: Analyze clinical cases for trends and collaborate on potential improvements.
- Risk Management: Identify risks and develop strategies to mitigate them concerning medical practices and patient safety.
- Training and Education: Assist in the development and delivery of training programs for medical personnel to ensure ongoing education on regulatory changes.
- Audit and Reporting: Conduct regular audits to evaluate compliance with internal policies and regulatory standards, preparing reports as necessary.
- Healthcare credentials as a nurse, Nurse Practitioner, or Physician Assistant.
- A minimum of 5 years' experience in medical regulatory roles with a focus on compliance.
- In-depth knowledge of local regulatory requirements in the relevant countries.
- Strong analytical skills and the ability to interpret complex regulations.
- Commitment to ethical standards in medical practice and patient care.
- Ability to thrive in a dynamic environment and manage multiple priorities.
Removery LLC offers a stable and rewarding career in a fast-paced industry, with opportunities for advancement and a supportive team environment. We are committed to diversity and inclusion, valuing a wide range of experiences and perspectives.
