Director of Compliance (Med Device) in Nashville, TN

Are you an experienced compliance leader in the medical device industry? We are seeking a Director of Compliance (Med Device) in Nashville, TN to oversee regulatory adherence, implement compliance programs, and ensure operational integrity in a dynamic healthcare environment. This role is ideal for a strategic thinker with a deep understanding of FDA regulations, ISO standards, and healthcare compliance frameworks.

As the Director of Compliance (Med Device) in Nashville, TN, you will play a critical role in safeguarding the organization’s regulatory standing, mitigating risks, and fostering a culture of compliance excellence. If you have a proven track record in medical device compliance, internal audits, and regulatory affairs, this position offers a challenging yet rewarding opportunity to lead compliance initiatives and uphold industry standards.

About This Role

The Director of Compliance (Med Device) in Nashville, TN is responsible for designing, executing, and maintaining comprehensive compliance programs that align with industry regulations and corporate policies. This role requires expertise in navigating complex regulatory landscapes, implementing training programs, and ensuring adherence to federal, state, and international compliance requirements.

As a senior compliance executive, you will collaborate with cross-functional teams, oversee internal audits, and interact with regulatory agencies such as the FDA, ISO, and OIG. Your leadership will be instrumental in guiding ethical business practices, risk management strategies, and operational compliance throughout the organization. If you are passionate about maintaining regulatory integrity while supporting business growth, this role presents an excellent career advancement opportunity.

Key Responsibilities – Director of Compliance (Med Device) in Nashville, TN

Develop and Implement Compliance Programs

Establish and maintain company-wide compliance policies and procedures.
Ensure alignment with FDA, ISO, HIPAA, and other industry regulations.
Conduct risk assessments to identify and mitigate compliance vulnerabilities.

Oversee Regulatory Adherence and Risk Management

Monitor evolving regulatory requirements and update compliance strategies accordingly.
Develop risk mitigation plans to address potential compliance issues.
Ensure adherence to international medical device compliance standards.

Lead Internal Audits and Compliance Investigations

Plan and conduct internal audits to assess compliance effectiveness.
Investigate compliance breaches and recommend corrective actions.
Work closely with legal teams to resolve compliance-related concerns.

Train and Educate Staff on Compliance Policies

Develop training programs to enhance compliance awareness among employees.
Conduct workshops and seminars on regulatory updates and ethical practices.
Ensure all employees understand company compliance expectations.

Manage Regulatory Agency Interactions

Serve as the primary point of contact for FDA audits, ISO inspections, and government inquiries.
Prepare and submit regulatory documentation as required.
Address compliance findings and implement necessary corrective measures.

Ensure Ethical Business Practices

Establish frameworks for conflict-of-interest disclosures and code-of-conduct enforcement.
Oversee adherence to anti-bribery and anti-corruption policies.
Implement monitoring mechanisms to ensure continued ethical compliance.

Support Product Development and Market Entry Compliance

Work with R&D, manufacturing, and quality teams to ensure compliance during product development.
Oversee regulatory submissions and approvals for new products.
Ensure compliance with labeling and marketing claims.

Monitor Compliance Performance and Continuous Improvement

Develop and track key performance indicators (KPIs) for compliance programs.
Identify opportunities to enhance regulatory processes and compliance efficiencies.
Foster a culture of continuous improvement and proactive compliance management.

What The Client is Looking For in You

To excel as the Director of Compliance (Med Device) in Nashville, TN, you should bring a combination of regulatory expertise, strategic leadership, and a proactive compliance mindset. The ideal candidate will possess:

Extensive Compliance & Regulatory Knowledge – A strong background in FDA regulations, ISO standards, HIPAA, and healthcare compliance frameworks is essential. You must be well-versed in industry best practices and evolving regulatory requirements.
Proven Track Record in Compliance Leadership – Experience in designing and implementing compliance programs, leading audits, and ensuring regulatory adherence at an executive level.
Risk Management & Analytical Thinking – The ability to assess compliance risks, develop mitigation strategies, and ensure company-wide adherence to regulatory policies.
Strong Leadership & Cross-Functional Collaboration – The ability to work closely with executive teams, legal departments, quality assurance, and operational leaders to foster a culture of compliance.
Experience in Internal Audits & Investigations – Prior experience conducting internal audits, compliance investigations, and regulatory reporting to ensure an organization’s integrity.
Excellent Communication & Training Capabilities – Strong skills in developing and delivering compliance training programs for employees at all levels.
Ethical Business Practices & Integrity – A deep commitment to ethical standards, transparency, and ensuring compliance with anti-bribery, anti-corruption, and corporate integrity policies.
Attention to Detail & Process Improvement – A sharp eye for detail in regulatory documentation and the ability to enhance compliance processes for greater efficiency.

If you have a passion for compliance, regulatory strategy, and ensuring business integrity, this role is a prime opportunity to make a lasting impact in the medical device industry.

Why This Opportunity Stands Out

The Director of Compliance (Med Device) in Nashville, TN role offers a unique opportunity to lead compliance initiatives in a rapidly growing medical device company. Here’s why this position is an exceptional career move:

Be a Compliance Leader in a High-Growth Industry – Join a company at the forefront of medical technology and play a critical role in shaping compliance frameworks that drive business success.
Direct Interaction with Executive Leadership – Work closely with the CEO, legal counsel, and regulatory affairs teams to ensure enterprise-wide compliance.
Impact Patient Safety & Product Integrity – Your work will directly influence the safety and efficacy of medical devices that improve lives worldwide.
Competitive Compensation & Executive Benefits – Enjoy a lucrative salary package, performance-based bonuses, and comprehensive benefits, including healthcare, retirement plans, and executive-level perks.
Opportunities for Career Growth & Development – Gain leadership exposure in regulatory affairs, corporate compliance, and strategic risk management, with room for career advancement.
Work in a Collaborative & Ethical Culture – Join an organization that values transparency, integrity, and continuous improvement in compliance standards.
Global Regulatory Exposure – Get hands-on experience managing compliance across international markets, broadening your professional expertise.

If you’re seeking a leadership role in compliance that combines strategy, innovation, and regulatory excellence, this is the perfect career move.

FAQs About the Role

Q: What industries should I have experience in?
A: You should have extensive experience in the medical device industry, specifically in regulatory compliance, FDA adherence, and ISO certification processes. Experience in pharmaceuticals or healthcare compliance may also be beneficial.

Q: Is relocation required for this position?
A: The role is based in Nashville, TN, and requires an on-site presence. Relocation assistance may be available for the right candidate.

Q: What is the reporting structure for this role?
A: The Director of Compliance (Med Device) in Nashville, TN will report directly to the Chief Compliance Officer (CCO) and work closely with legal, quality assurance, and executive teams.

Q: What level of experience is required?
A: Candidates should have 10+ years of experience in medical device compliance, regulatory affairs, or a related field. A track record in leading compliance programs and internal audits is a plus.

Q: What is the expected travel requirement?
A: While the role is based in Nashville, some travel may be required for regulatory audits, training sessions, and compliance meetings.

Q: What qualifications and skills are required?
A: A bachelor’s or master’s degree in Regulatory Affairs, Healthcare Compliance, Law, or a related field is preferred. Certifications such as RAC (Regulatory Affairs Certification) or CHC (Certified in Healthcare Compliance) are highly desirable.

Q: What are the main compliance regulations I’ll be overseeing?
A: The primary compliance frameworks include FDA 21 CFR Part 820, ISO 13485, HIPAA, Anti-Kickback Statutes, False Claims Act, and other industry-specific regulations.

Q: What is the timeline for hiring and onboarding?
A: The company aims to fill this position within the next 60–90 days. Onboarding will involve training on company policies, deep dives into regulatory frameworks, and collaboration with compliance teams.

What Remuneration Can You Expect from This Job?

As the Director of Compliance (Med Device) in Nashville, TN, you can expect a highly competitive compensation package that reflects the strategic importance of this role. The base salary for this position typically ranges between $180,000 – $230,000 per year, depending on experience, industry expertise, and track record in compliance leadership.

Beyond the base salary, this role offers performance-based bonuses tied to compliance program effectiveness, regulatory adherence, and risk mitigation strategies. Equity options or stock grants may also be available, providing a chance to share in the company’s long-term success.

The benefits package includes comprehensive healthcare coverage (medical, dental, and vision), a 401(k) retirement plan with company matching, executive-level perks, paid time off, and professional development opportunities. Additional benefits may include a relocation package, travel allowances, and participation in industry conferences to stay ahead of regulatory changes.

This is an opportunity not only to earn a lucrative financial package but also to make a significant impact in the medical device industry, ensuring regulatory excellence and business integrity. If you’re a compliance expert looking for an executive leadership role, this position provides both financial rewards and career growth.

How to Apply for This Director of Compliance (Med Device) Position in Nashville, TN

If you are a seasoned compliance leader with a proven track record in regulatory affairs within the medical device industry, we invite you to apply for the Director of Compliance (Med Device) in Nashville, TN. This is an exceptional opportunity to lead compliance initiatives, shape corporate governance, and ensure adherence to global regulatory standards.

To apply, please submit your resume and a cover letter detailing your experience in regulatory compliance, risk management, and corporate integrity within the medical device sector.

This role offers a rewarding opportunity to work with a forward-thinking medical device company, ensuring that products meet the highest regulatory standards while driving ethical business practices. Apply today to take the next step in your compliance leadership career as a Director of Compliance (Med Device) in Nashville, TN!

For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.

Tags:

Job Category: Director of Compliance

Job Type: Full Time

Job Location: Nashville