Manager of Compliance and Medical Affairs
2 weeks ago
Position Title: Manager of Compliance and Medical Affairs
ABOUT REMOVERY
Join us in our mission to redefine the tattoo removal experience. Removery is a pioneering, collaborative organization specializing in laser tattoo removal, with operations across multiple countries. We are dedicated to making a significant impact in the lives of individuals seeking change through our tattoo removal services. Our vision is to maintain professionalism, authenticity, and approachability. The work environment at Removery is characterized by a clinically validated, human-centered removal process that delivers results. Our team members are honored to assist clients in their journey towards self-empowerment. We uphold the values of Trust, Passion, Purpose, Focus, and Effectiveness. Our studio teams are extensively trained and deeply committed to their roles, ensuring that the tattoo removal process is accessible, technologically advanced, and conducted in safe, comfortable settings.
Founded through the merger of leading tattoo removal brands, Removery boasts over a century of combined experience and has successfully completed over a million treatments, providing clients with an unparalleled service experience. Headquartered in a vibrant city, we are the foremost provider of laser tattoo removal services globally, utilizing state-of-the-art technology, including the innovative PicoWay laser system, to ensure safe and effective tattoo removal. We are poised to expand our network significantly in the coming years.
POSITION OVERVIEW:
We are in search of a Manager of Compliance and Medical Affairs to oversee and uphold the highest standards of medical and regulatory adherence across our locations. This pivotal role involves offering strategic guidance to our headquarters and field teams, ensuring compliance with local regulations, and promoting excellence in client care and safety.
The manager will also be responsible for overseeing our approved clinical trials, coordinating the Clinical Advisory Board, and serving as the primary liaison among medical directors, credentialed providers, and regional operations regarding credentialing and regulatory matters.
Key Responsibilities:
- Regulatory Compliance: Remain informed about regulatory obligations in various regions; develop and implement policies to ensure compliance across all locations. Maintain an updated schedule of state and federal regulations.
- Establish and maintain a comprehensive library of state-regulated agreements for credentialed providers.
- Collect and manage all necessary licenses for medical directors and credentialed providers.
- Ensure that all required documentation is readily available at locations.
- Verify that signage, LSO status, and other safety measures comply with regulations.
- Medical Director Liaison: Engage with Medical Directors, ensuring they are well-acquainted with their teams and coordinate meetings.
- Ensure Medical Directors approve any protocol modifications and that agreements are current.
- Clinical Trial Coordination: Manage the approval process for clinical trials.
- Ensure all participant documentation is accurate and properly filed.
- Guarantee compliance with clinical trial protocols.
- Contribute to and oversee the authorship of any research-related publications.
- Clinical Advisory Board Coordination: Organize all meetings of the Clinical Advisory Board.
- Document meeting minutes and distribute them promptly.
- Ensure that any protocol changes are documented and agreed upon.
- Quality Assurance: Participate in quality assurance initiatives to enhance patient care, treatment outcomes, and customer satisfaction. Serve as the subject matter expert for safety and regulatory issues.
- Incident Reporting: Report on clinical and safety incidents, analyze data trends, and collaborate on strategies to minimize incidents.
- Clinical Case Review Reporting: Analyze clinical cases, identify trends, and collaborate on improvements.
- Review anticipated and unanticipated side effects.
Risk Management: Identify potential risks and implement strategies to mitigate them concerning medical practices and patient safety.
Training and Education: Assist in developing and delivering training programs for medical staff, ensuring ongoing education on regulatory changes and best practices.
Audit and Reporting: Conduct regular audits to evaluate compliance with internal policies and regulatory standards; prepare reports for leadership and regulatory bodies as necessary.
Experience:
- At least 5 years of experience in medical regulatory roles within healthcare or a related field, with a strong focus on compliance and regulatory affairs.
- Healthcare credentials as a nurse, nurse practitioner, or physician assistant.
- Accredited as a Laser Safety Officer or the ability to obtain such accreditation.
- Comprehensive knowledge of local regulatory requirements, including FDA regulations and other relevant healthcare compliance standards.
- Strong analytical and problem-solving skills, with the ability to interpret complex regulations and develop actionable strategies.
- Commitment to maintaining the highest ethical standards in medical practice and patient care.
- Ability to thrive in a dynamic, fast-paced environment and manage multiple priorities effectively.
Removery offers a stable, long-term career in a growing, rewarding, fast-paced, and enjoyable industry. You will be part of a supportive and close-knit team with opportunities for advancement and the chance to engage in meaningful work. We provide a competitive salary based on experience, along with a comprehensive benefits package that includes:
- Comprehensive Medical, Dental, and Vision coverage
- Short-term and Long-term Disability Insurance
- Group life insurance at no cost, with options to purchase additional coverage
- Generous sick leave and vacation time
- Company-paid holidays
- Referral bonus program
- Employee Assistance Program
- Collaborative work environment with a positive culture
- Ongoing comprehensive training
We are an Equal Opportunity Employer and do not discriminate based on race, ethnicity, religion, creed, sex, gender, gender identity, pregnancy, national origin, ancestry, age, disability, veteran status, marital status, genetic information, sexual orientation, political affiliation, or any other non-job-related factors. We value diversity and are committed to building a team that fosters an inclusive culture representing a global perspective of experiences, skills, backgrounds, and expertise.
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Texas, United States Removery Full timePosition Title: Manager of Medical Compliance and Regulatory AffairsABOUT REMOVERYJoin us in our mission to redefine the tattoo removal experience. Removery is a pioneering, collaborative organization specializing in laser tattoo removal, with operations across multiple countries. We are dedicated to making a significant impact in the lives of individuals...
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