Manager of Medical Compliance and Regulations
1 week ago
Removery LLC is in search of a dedicated Manager of Medical, Regulatory and Compliance to ensure the utmost standards of medical and regulatory adherence across our operational locations. This pivotal role is responsible for guiding our headquarters and field teams, ensuring compliance with local regulations, and enhancing client care and safety.
Key Responsibilities- Regulatory Compliance: Remain informed about regulatory requirements in Australia, Canada, and the United States. Develop and implement comprehensive policies and procedures to ensure compliance across all locations.
- Medical Director Liaison: Collaborate with Medical Directors, ensuring they are well-integrated with their teams and that all protocol changes are documented and agreed upon.
- Clinical Trial Coordination: Manage the IRB approval process, ensuring all participant documentation is compliant and appropriately filed.
- Clinical Advisory Board Coordination: Organize CAB meetings, ensuring all protocol changes are documented and communicated effectively.
- Quality Assurance: Contribute to quality assurance initiatives to monitor and enhance patient care and treatment outcomes.
- Incident Reporting: Analyze clinical and safety incidents, identifying trends and collaborating on strategies to mitigate risks.
- Risk Management: Identify potential risks related to medical practices and compliance, implementing effective mitigation strategies.
- Training and Education: Assist in the development and delivery of training programs for medical staff, focusing on regulatory changes and best practices.
- Audit and Reporting: Conduct regular audits to assess compliance with internal policies and regulatory standards, preparing reports for leadership as necessary.
- Credentialed in healthcare as a nurse, nurse practitioner, or physician assistant.
- A minimum of 5 years' experience in medical regulatory roles with a strong focus on compliance.
- In-depth knowledge of local regulatory requirements, including FDA regulations.
- Strong analytical and problem-solving skills, with the ability to interpret complex regulations.
- Commitment to maintaining high ethical standards in medical practice and patient care.
- Ability to thrive in a dynamic environment and manage multiple priorities effectively.
Removery LLC offers a stable and rewarding career in a growing industry, with opportunities for advancement and a supportive team environment. We value diversity and are committed to building an inclusive culture that reflects a global perspective.
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Austin, Texas, United States REMOVERY LLC Full timePosition OverviewRemovery 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...
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Austin, Texas, United States REMOVERY LLC Full timePosition OverviewRemovery 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...
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