Compliance Director

Company: Sequel Med Tech
Location: Marlborough
Posted on: May 24, 2025

Job Description:

About Sequel
Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.

Job Overview
The Director of Compliance will play a key role in executing Sequel Med Tech's compliance program to ensure adherence to FDA regulations, the Sunshine Act, and other applicable healthcare laws and industry standards. Reporting to the Vice President of Legal, this role will be responsible for responding to complaints, conducting investigations, performing ongoing monitoring, and ensuring compliance with all relevant reporting obligations. The ideal candidate will have experience in compliance within an FDA-regulated company, preferably in the medical device or pharmaceutical industry.

Job Responsibilities and Essential Duties

• Compliance Program Execution: Implement and maintain Sequel's compliance program, ensuring adherence to FDA regulations, fraud and abuse laws, and industry best practices.
• Investigations & Monitoring: Lead investigations related to compliance concerns, employee or customer complaints, and potential violations of company policies. Conduct ongoing monitoring to identify and mitigate compliance risks.
• Regulatory Reporting: Ensure compliance with federal and state reporting requirements, including Sunshine Act (Open Payments) reporting, state transparency laws, and other relevant obligations.
• Training & Education: Develop and deliver compliance training programs for employees and key stakeholders to promote awareness and understanding of regulatory requirements. Foster a strong sense of compliance and ethics, including personal accountability, at all levels of the organization.
• Policies & Procedures: Establish, update, and enforce compliance policies, procedures, and guidelines in alignment with industry standards and regulatory requirements.
• Third-Party Compliance: Conduct due diligence and compliance risk assessments of vendors, distributors, and business partners. Oversee contracts to ensure appropriate compliance provisions are included.
• Audits & Risk Assessments: Conduct internal audits and risk assessments to identify gaps and implement corrective actions to mitigate potential compliance risks.
• Collaboration & Advisory: Work cross-functionally with Legal, Quality, Regulatory, Sales, and other departments to integrate compliance considerations into business operations. Provide guidance on interactions with healthcare professionals (HCPs) and healthcare organizations (HCOs). Offer risk identification and mitigation support in the development and implementation of business strategies and tactics.
• Government Inquiries & Reporting: Support responses to government inquiries, inspections, and enforcement actions as needed. Partner with the VP of Legal to ensure timely and accurate regulatory submissions and disclosures.
• Continuing Education: Keep abreast of changing regulations and industry best practices.
  Minimum Requirements
  • Bachelor's degree or commensurate experience required; JD, MBA, or equivalent advanced degree preferred.
  • 10+ years of experience in compliance, legal, or regulatory affairs within an FDA-regulated medical device, pharmaceutical, or biotech company.
    Required Knowledge, Skills and Abilities
    • Strong knowledge of FDA regulations, Sunshine Act, Anti-Kickback Statute, False Claims Act, and HIPAA.
    • Experience conducting investigations, risk assessments, and compliance audits.
    • Ability to interpret complex regulations and translate them into practical business solutions.
    • Strong communication, leadership, and project management skills.
    • High ethical standards, integrity, and ability to handle confidential matters with discretion.
    • Able and willing to travel occasionally (up to 30%) to company meetings, audits, and industry-specific conferences.
    • Experience with compliance software and reporting tools is a plus.
      Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
      
      At Sequel, we believe that when you thrive, we thrive. That's why we've designed a benefits package that's as thoughtful as it is generous. From day one, you're automatically enrolled in our 401k plan-no waiting, no worries-with a 6% company match and 100% immediate vesting. We prioritize your well-being, especially for our employees and their families living with diabetes, with capped out-of-pocket insulin costs and GLP-1 coverage across all plans. With multiple medical plans through Aetna, including a 100% company-paid high deductible plan paired with employer HSA contributions, you can select what suits your needs. Additional benefits include vision and dental plans, employer-paid short-term disability, and voluntary options like accident and pet insurance.
      
      Need time to relax and recharge? You'll enjoy flexible PTO and generous paid holidays, all while being part of a culture that values hard work, fun, and support. We don't just offer jobs-we offer careers that build futures. Join us, and let's grow together!
      
      
      Environmental/Safety/Physical Work Conditions
      • Ensures environmental consciousness and safe practices are exhibited in decisions
      • Use of computer and telephone equipment and other related office accessories/devices to complete assignments
      • May work extended hours during peak business cycles
      • Physical requirements such as lifting specific weights
      • Some travelling is expected
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Keywords: Sequel Med Tech, Marthas Vineyard , Compliance Director, Executive , Marlborough, Massachusetts