Compliance Officer at Biostem Technologies

Company Overview:
BioStem Technologies, founded in 2014 and located in South Florida, is a leading medical technology company focused on advanced wound care and regenerative medicine. We develop and commercialize placental tissue allografts, cutting-edge wound care products, and surgical solutions aimed at improving patient outcomes. As we continue our rapid growth and expansion, we seek a seasoned Compliance Officer to join our leadership team, ensuring that we maintain the highest standards of regulatory and ethical compliance across our operations.

Why BioStem Technologies? BioStem Technologies is an industry leader in regenerative medicine, delivering innovative solutions with products such as AmnioWrap2, Vendaje, Vendaje AC, and Vendaje Optic that transform the way wounds are treated. Located in South Florida, BioStem offers a collaborative, high-impact environment where compliance plays a critical role in enabling breakthrough technologies. As a member of our team, you'll contribute to a mission-driven organization poised for rapid growth in the MedTech space. Our innovative approach is making a tangible difference in patient outcomes, and we are committed to leading the future of wound care through advanced therapeutic solutions. If you want to be part of a forward-thinking company that values integrity, innovation, and operational excellence, BioStem is the place for you.

Position Summary:
The Compliance Officer will oversee and manage BioStem Technologies' comprehensive compliance program, ensuring adherence to all applicable federal, state, and international regulations. Reporting to the CEO, this role will provide critical guidance on corporate compliance, risk management, and ethical standards while developing policies that align with BioStem's business objectives. The Compliance Officer will collaborate with senior leadership, legal, regulatory, and operational teams to maintain the integrity of BioStem's compliance efforts, ensuring that the company operates in accordance with healthcare regulations, FDA requirements, and global anti-bribery laws.

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.

Qualifications:

• Proven leadership experience in healthcare compliance, regulatory affairs, or legal, with a focus on FDA-regulated environments.
• Expertise in developing and managing corporate compliance programs in public companies.
• Strong knowledge of healthcare regulations, including FDA, CMS, SOX, HIPAA, and anti-bribery laws (FCPA).
• Exceptional leadership, communication, and organizational skills, with a demonstrated ability to manage compliance issues in a global setting.
• Bachelor's degree in law, business administration, or a related field (Master's degree or JD preferred).
• Familiarity with compliance management software and risk assessment tools.

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