Senior Compliance Manager

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting‑edge regenerative medicine. Our commitment to innovation, patient‑centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).

Reporting to the Chief Compliance Officer, the Compliance Manager is responsible for the day‑to‑day leadership, operations, and program management of the Vericel Compliance program, which includes but is not limited to monitoring, training, development of policies and procedures, communications, third‑party due diligence, investigations, and risk assessment auditing and reporting. This individual is the main point‑of‑contact and compliance lead for the commercial and medical organizations within Vericel, as well as a primary contact for all parts of the business with respect to day‑to‑day contracting needs and other operational matters of a legal nature.

The ideal candidate will have previous Artificial Intelligence experience to leverage expertise to build an efficient and scalable compliance program.

This position is in‑office from Monday – Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays.

• Build an effective and scalable compliance program, leveraging experience and AI expertise.
• Serve as the legal representative in connection with the Company’s Medical, Legal and Regulatory (MLR) review process.
• Utilize in‑depth knowledge of the requirements of the Anti‑Kickback Statute as they apply to commercial activities, the on‑label promotion of the Company’s commercial products, as well as other laws, guidance and industry codes governing key biotechnology compliance areas.
• Serve as a trusted compliance advisor to the commercial and medical organizations.
• Establish effective working relationships and build credibility within the Company, especially at senior management and operational leadership levels, implementing a culture of trust, integrity, transparency, and openness.
• Develop and deliver engaging compliance training and communications tailored to the needs of the business (including monitoring online and live training campaigns).
• Support the annual needs assessments for HCP engagements, ensuring compliance with all regulatory bodies.
• Manage the Company’s compliance with Open Payments reporting obligations.
• Responsible for constructing procedures governing internal investigations as well as for the conduct of such investigations.
• Develop and execute monitoring plans to monitor in‑person and transactional business activities.
• Support Vericel’s data privacy and protection efforts.
• Provide support on other matters requested by Legal Management, including with respect to litigation matters, and contracting responsibilities, as needed.
• Assist in long‑term strategic planning for the compliance program in response to effectiveness measures, continuous evolution activities and industry‑leading best practices for effective compliance programs. Remain abreast of industry best practices and changing standards.

• Bachelor’s degree and experience in Healthcare and Corporate Compliance is required.
• 5-8+ years of experience in corporate compliance in the medical device, pharmaceutical or biotech industry at companies with a marketed, commercial product.
• Successful AI application to design efficient compliance review processes.
• Knowledge of Health Care Compliance programs and policies, the Adva Med code of conduct, state and federal open payments laws, Federal health care programs, and FDA requirements required.
• Deep understanding of healthcare compliance laws, regulations, and industry codes of practice governing medical device and biopharmaceutical industry business practice, including but not limited to commercial, medical affairs, market access, and clinical development activities.
• Proficiency in Microsoft Office Suite, Veeva Vault, and contract management systems.
• Highly familiar with the current U.S. life science marketplace, including substantive knowledge of…