Medical Regulatory and Compliance Manager

2 months ago

Austin, United States REMOVERY LLC Full time
Job DescriptionJob Description

Regulatory and Compliance Manager

About Removery 

Join us in our journey of normalizing tattoo removal around the world Removery is an innovative, collaborative multi-location laser tattoo removal company, currently operating in the USA, Canada, and Australia. We take pride in our mission to make a real difference in people’s lives by supporting them as they embrace change through their tattoo removal journey. Our vision is to remain professional, genuine, and approachable. Removery’s working environment is driven by a clinically proven, human-oriented, removal process that achieves results. Our teams feel privileged to play a role in empowering our clients to be who they want to be. As such, Removery team members live by the values of Trust, Passion, Purpose, Focus and Effectiveness. Studio teams are highly trained and passionate about what they do.  We strive to make it easy for those with unwanted tattoos to remove them - in the most accessible locations, with the best technology, in safe and comfortable environments and with studio teams who will support them throughout their journey.
Removery was formed in 2019 through a merger of the four leading tattoo removal brands in North America. The underlying businesses have operated a combination of 100+ years and have performed more than 1,000,000 treatments, enabling us to offer clients an unrivaled treatment experience. Based in Austin, TX, Removery is the only scaled, pure play provider of laser tattoo removal services in the world. We use best in class technology utilizing the innovative PicoWay® laser equipment to remove tattoos safely and effectively. The foundation is in place to build a network of 400+ locations across the US, Canada, and Australia over the next 5 years.

Position Overview:

Removery is seeking a Manager of Medical, Regulatory and Compliance to oversee and ensure the highest standards of medical and regulatory compliance across our locations in Australia, Canada, and the United States. This key role involves providing tactical direction to our HQ and Field teams, ensuring adherence to local regulations, and driving excellence in client care and safety. Additionally, the manager will be responsible for our IRB approved clinical trials, Clinical Advisory Board co-ordination and be the key liaison between all medical directors, credentialed providers, and regional operations for credentialing and other regulatory driven matters.

Key Responsibilities:
  • Regulatory Compliance: Stay updated on regulatory requirements (including but not limited to those certain regulatory requirements related to laser registrations and inspections and the requirements of certain credentialed employees) in Australia, Canada, and the United States; develop and implement policies and procedures to ensure compliance across all locations.
    • Maintain up to date schedule of state and federal regulations for all markets.
    • Create, update, and maintain library of all appropriate state regulated agreements for credentialed providers.
    • Collect and maintain all licenses for all medical directors and credentialed providers.
    • Ensure all appropriate documentation is on hand at locations.
    • Ensure signage, LSO status and all other regulatory safety measures are in compliance.
  • Medical Director Liaison
    • Engage with the Medical Directors for each state, ensure they are known to their teams, coordinate meetings.
    • Ensure Medical Directors are signed off on any protocol changes and agreements are kept up to date.
  • Clinical Trial co-ordination
    • Own the IRB approval process.
    • Ensure all participant documentation is appropriate and filed.
    • Ensure compliance with IRB protocols.
    • Contribute to and manage authorship of any articles resulting from the research.
  • Clinical Advisory Board co-ordination:
    • Coordinate all CAB meetings.
    • Take minutes and circulate in a timely manner.
    • Ensure any protocol changes are documented, circulated, and agreed on.
  • Quality Assurance: Contribute to quality assurance programs to monitor and enhance the quality of patient care, treatment outcomes, and customer satisfaction.
    • Function as the SME for all safety and regulatory matters.
  • Incident reporting:
    • Report on clinical and safety incidents.
    • Analyze trends within the data and collaborate on ways to reduce incidents.
  • Clinical case review reporting:
    • Report on clinical cases, analyze trends within the data and collaborate on improvements.
    • Review trends in any anticipated and unanticipated side effects.
  • Risk Management: Identify potential risks and implement mitigation strategies related to medical practices, compliance issues, and patient safety.
  • Training and Education: Contribute to development and delivery of training programs for medical staff, ensuring ongoing education on regulatory changes and best practices.
  • Audit and Reporting: Conduct regular audits to assess compliance with internal policies and regulatory standards; prepare reports for executive leadership and regulatory bodies as needed.
Experience:
  • Health care credentialled as a nurse (LPN, RN), Nurse Practitioner (FNP, NP, or DNP) or Physician Assistant (PA).
  • Minimum of 5 years’ experience in medical regulatory roles within healthcare or a related industry, with a strong emphasis on compliance and regulatory affairs.
  • LSO accredited or ability to become an LSO.
  • Regulatory Knowledge: In-depth knowledge of local regulatory requirements in Australia, Canada, and the United States, including FDA regulations (for the US), and other relevant healthcare compliance standards.
  • Analytical Skills: Strong analytical and problem-solving abilities, with the capacity to interpret complex regulations and develop actionable strategies.
  • Ethical Standards: Commitment to maintaining the highest ethical standards in medical practice, compliance, and patient care.
  • Adaptability: 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 fun industry. You will be part of a supportive and close-knit team with room for advancement within the Company, and the opportunity to perform purposeful work. Removery is proud to offer a competitive salary based upon experience, in tandem with a competitive benefits package including:
  • Comprehensive Medical, Dental, and Vision with HRA option
  • STD and LTD
  • $50,000 group life insurance at no cost to you Plus, the option to purchase more.
  • 40-hours sick time and 80-hours vacation
  • Eight (8) company paid holidays.
  • A Team Member Referral Bonus Program
  • Employee Assistance Program – benefits to help you manage daily responsibilities.
  • Collaborative work environment with an amazing 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 values an inclusive culture that represent a global perspective of experiences, skills, backgrounds, and expertise.
 

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