Compliance Officer

3 weeks ago

Fort Lauderdale, Florida, United States Biostem Technologies Full time

Company Overview:
BioStem Technologies is a leading medical technology company focused on advanced wound care and regenerative medicine. Our comprehensive compliance program ensures adherence to all applicable federal, state, and international regulations, enabling us to develop and commercialize innovative solutions for patients worldwide.

Why BioStem Technologies?
We are an industry leader in regenerative medicine, delivering cutting-edge wound care products and surgical solutions that transform the way wounds are treated. Our collaborative, high-impact environment values integrity, innovation, and operational excellence, making us an ideal place for a seasoned Compliance Officer to contribute to our mission-driven organization.

Position Summary:
The Compliance Officer will oversee and manage BioStem Technologies' comprehensive compliance program, ensuring adherence to all applicable federal, state, and international regulations. This role will provide critical guidance on corporate compliance, risk management, and ethical standards while developing policies that align with BioStem's business objectives.

Key Responsibilities:

  • Compliance Program Management:
    • Develop, implement, and regularly update BioStem's Corporate Compliance Program to ensure it meets U.S. Sentencing Guidelines for Organizations and Office of Inspector General (OIG) guidance.
    • Oversee and enforce the company's Anti-Corruption, Code of Conduct, and other compliance-related policies.
    • Ensure that the company complies with FDA regulations, CMS requirements, SOX (Sarbanes-Oxley), HIPAA, and international healthcare compliance laws.
    • Manage day-to-day operations of the compliance department and chair BioStem's Compliance Committee.
  • Regulatory Monitoring & Reporting:
    • Maintain expertise in U.S. and international medical device standards and regulations, providing guidance to internal teams.
    • Monitor changes in federal, state, and international laws and ensure that BioStem's compliance policies are updated accordingly.
    • Oversee BioStem's compliance with federal import/export regulations and ensure proper screening of vendors and customers.
  • Compliance Training & Education:
    • Develop and implement training programs for employees regarding compliance policies and updates.
    • Conduct regular compliance training, ensuring employees understand and follow BioStem's standards of conduct.
  • Risk Assessment & Management:
    • Lead risk assessments to identify potential compliance vulnerabilities within BioStem's operations.
    • Develop corrective action plans for compliance issues and monitor implementation to prevent recurrence.
  • Internal Audits & Investigations:
    • Coordinate with Internal Audit to ensure robust auditing of compliance processes and systems.
    • Investigate and respond to compliance breaches, ensuring appropriate corrective measures are taken.
  • Policy Development & Enforcement:
    • Update and enforce BioStem's policies, ensuring adherence to industry best practices and legal requirements.
    • Work closely with Legal and Regulatory Affairs to ensure compliance with marketing and off-label promotion laws.
  • Leadership & Team Management:
    • Lead the compliance team, fostering a culture of ethical behavior and regulatory adherence across the organization.
    • Provide regular reports to the CEO and the Board of Directors on the effectiveness of the compliance program.

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