Are you a highly experienced compliance professional looking to make a significant impact in the medical device industry? We are seeking a Chief Compliance Officer (Medical Device) in Charlotte, NC, to lead and oversee regulatory compliance, ethical business practices, and risk management initiatives. This executive role requires a proactive leader with a deep understanding of FDA regulations, ISO standards, and global medical device compliance frameworks.
As the Chief Compliance Officer (Medical Device) in Charlotte, NC, you will play a pivotal role in ensuring that all business operations, product development, and sales activities adhere to industry regulations and ethical standards. Your expertise will be essential in developing compliance strategies, mitigating risks, and fostering a culture of accountability across the organization. If you are passionate about maintaining the highest standards of regulatory integrity and ensuring corporate compliance in a rapidly evolving healthcare industry, we encourage you to apply.
About This Role
The Chief Compliance Officer (Medical Device) in Charlotte, NC is responsible for leading the compliance function and ensuring that the company operates within the legal and regulatory frameworks required for the medical device industry. This role demands a strategic thinker who can implement robust compliance programs, monitor regulatory changes, and provide guidance on risk management and corporate governance.
In this position, you will be responsible for aligning compliance efforts with business goals, coordinating with regulatory agencies, and driving continuous improvements in quality assurance. As a key member of the executive team, you will collaborate with legal, R&D, and commercial teams to ensure compliance is integrated into all aspects of the organization. The Chief Compliance Officer (Medical Device) in Charlotte, NC will play a critical role in safeguarding the company’s reputation and ensuring long-term success in a competitive market.
Key Responsibilities – Chief Compliance Officer (Medical Device) in Charlotte, NC
Develop and Oversee Compliance Programs
- Design and implement company-wide compliance policies, procedures, and protocols.
- Ensure alignment with FDA regulations, ISO standards, HIPAA, and other relevant compliance frameworks.
- Conduct regular compliance audits and risk assessments to identify potential regulatory issues.
Ensure Regulatory Compliance and Certification
- Oversee regulatory submissions, approvals, and audits required for medical device products.
- Maintain up-to-date knowledge of FDA, EU MDR, and global regulatory requirements.
- Work closely with R&D and quality assurance teams to ensure products meet all regulatory standards.
Lead Risk Management and Corporate Governance Initiatives
- Develop risk assessment frameworks to identify and mitigate compliance risks.
- Provide strategic guidance to the board and executive leadership on governance and ethical business practices.
- Establish internal controls to ensure financial, operational, and regulatory risks are properly managed.
Monitor and Report Compliance Metrics
- Establish key performance indicators (KPIs) to track compliance program effectiveness.
- Prepare reports for senior management and regulatory agencies on compliance status.
- Implement corrective action plans in response to compliance issues or audit findings.
Train and Educate Employees on Compliance Standards
- Develop and conduct compliance training programs for employees at all levels.
- Ensure staff understand regulatory obligations and corporate policies.
- Promote a culture of integrity and ethical decision-making within the company.
Manage Internal Investigations and Ethical Compliance
- Oversee internal investigations related to compliance breaches, whistleblower complaints, or regulatory violations.
- Develop and enforce disciplinary actions for non-compliance issues.
- Collaborate with legal teams to address compliance concerns and mitigate legal risks.
Ensure Data Privacy and Cybersecurity Compliance
- Implement and enforce HIPAA and data privacy policies for handling patient and customer information.
- Collaborate with IT teams to ensure cybersecurity compliance and protection of sensitive data.
- Stay informed on evolving data protection laws and best practices.
Liaise with Regulatory Agencies and External Auditors
- Serve as the primary point of contact for regulatory agencies, auditors, and certification bodies.
- Respond to inquiries, conduct regulatory inspections, and provide compliance documentation as needed.
- Ensure the company is prepared for any changes in industry regulations and compliance requirements.
What The Client is Looking For in You
To excel as the Chief Compliance Officer (Medical Device) in Charlotte, NC, you should be a results-driven compliance leader with a deep understanding of regulatory frameworks, risk management, and corporate governance within the medical device industry. The ideal candidate will bring:
- Extensive Experience in Medical Device Compliance – A strong background in FDA regulations, ISO 13485, EU MDR, HIPAA, and global compliance requirements.
- Proven Leadership in Compliance and Risk Management – Experience developing and overseeing compliance programs in a medical device or healthcare-related company.
- Strong Regulatory and Quality Assurance Knowledge – Ability to ensure product approvals, regulatory submissions, and quality assurance processes align with industry standards.
- Ethical and Strategic Decision-Making – A proactive mindset to address regulatory challenges while maintaining business integrity.
- Exceptional Communication and Training Skills – Ability to educate and guide employees on compliance policies, fostering a culture of accountability.
- Experience Handling Internal Investigations and Audits – Strong knowledge of conducting compliance audits, managing internal investigations, and ensuring corrective actions are implemented.
- Relationship Management with Regulatory Bodies – A track record of successful interactions with FDA, EU regulators, and other compliance agencies.
- Analytical and Detail-Oriented Approach – Ability to assess risks, review compliance reports, and implement best practices in corporate governance.
If you have a passion for ensuring regulatory excellence and ethical business practices, this role presents an exciting opportunity to lead compliance initiatives in a growing medical device company.
Why This Opportunity Stands Out
The Chief Compliance Officer (Medical Device) in Charlotte, NC role offers a unique opportunity to be at the forefront of compliance and regulatory strategy in a high-growth medical device company. Here’s why this position stands out:
- Executive Leadership Impact – As part of the senior leadership team, you will play a critical role in shaping the company’s compliance framework and ethical business practices.
- Opportunity to Strengthen Regulatory Excellence – Lead initiatives that ensure the highest compliance and regulatory standards in the medical device sector.
- Growing Industry & Market Expansion – Work in a rapidly evolving medical technology landscape where compliance is key to driving innovation and market success.
- Competitive Compensation & Benefits – Receive a lucrative salary, performance-based incentives, equity options, and a comprehensive executive benefits package.
- Collaboration with Top Industry Experts – Work alongside R&D, quality assurance, legal, and commercial teams to ensure seamless regulatory alignment.
- Influence Company-Wide Culture – Implement training programs and compliance initiatives that foster integrity, accountability, and a commitment to excellence.
- Work with Cutting-Edge Medical Technologies – Play a vital role in bringing life-changing medical devices to market while ensuring regulatory adherence.
If you are looking for a challenging yet rewarding executive role where you can drive compliance excellence and regulatory leadership, this opportunity is for you.
FAQs About the Role
Q: What industries should I have experience in?
A: You should have extensive experience in the medical device, healthcare, or pharmaceutical industries, with a strong focus on regulatory compliance and risk management.
Q: What is the expected reporting structure?
A: The Chief Compliance Officer (Medical Device) in Charlotte, NC will report directly to the CEO and collaborate closely with legal, R&D, quality assurance, and commercial teams.
Q: What are the key compliance areas this role will focus on?
A: This role will oversee FDA regulations, ISO 13485 compliance, HIPAA data privacy, EU MDR requirements, risk assessment, internal audits, and ethical business conduct.
Q: What qualifications are required for this position?
A: Candidates should have a bachelor’s or master’s degree in law, regulatory affairs, healthcare compliance, or a related field. A minimum of 10+ years of experience in regulatory compliance within the medical device industry is preferred.
Q: Does this role require travel?
A: Yes, some travel may be required for regulatory audits, industry conferences, and compliance training programs.
Q: What is the company’s approach to compliance culture?
A: The company prioritizes a proactive compliance culture, emphasizing transparency, ethical business practices, and ongoing employee training.
Q: Will this role involve managing external regulatory interactions?
A: Yes, you will serve as the primary liaison with regulatory bodies such as the FDA, ISO auditors, and EU MDR agencies.
Q: What is the expected timeline for hiring?
A: The company aims to fill this position within 60–90 days and will provide a structured onboarding process to align compliance strategies with business objectives.
What Remuneration Can You Expect from This Job?
As the Chief Compliance Officer (Medical Device) in Charlotte, NC, you can expect a highly competitive executive compensation package that reflects your leadership role in ensuring regulatory excellence and corporate integrity. The base salary for this position ranges between $220,000 – $300,000 per year, depending on experience, industry expertise, and proven success in compliance leadership.
Beyond the base salary, this role includes performance-based bonuses and incentives tied to key compliance metrics such as regulatory adherence, risk mitigation, and successful audit outcomes. Equity options or stock grants may also be offered, providing an opportunity to contribute to and benefit from the company’s long-term growth.
Additional executive benefits include a comprehensive healthcare package (medical, dental, and vision), a 401(k) retirement plan with company matching, executive travel allowances, and paid time off (PTO). Relocation assistance may also be available for candidates moving to Charlotte, NC.
This position not only offers a lucrative financial package but also presents the opportunity to shape the compliance culture of a growing medical device company while working alongside an innovative leadership team in a dynamic and highly regulated industry.
How to Apply for This Chief Compliance Officer (Medical Device) Position in Charlotte, NC
If you are a compliance leader with a proven track record in regulatory affairs, risk management, and corporate governance within the medical device industry, we invite you to apply for the Chief Compliance Officer (Medical Device) in Charlotte, NC. This executive opportunity will allow you to drive compliance excellence, uphold ethical business practices, and lead regulatory strategies for a high-growth medical device company.
To apply, please submit your resume and a cover letter detailing your experience in regulatory compliance, FDA & ISO requirements, risk mitigation, and corporate integrity initiatives within the medical device sector.
This role offers a rewarding opportunity to lead a compliance team, enhance regulatory frameworks, and make a lasting impact in the medical technology industry. Apply today to take the next step in your executive career as a Chief Compliance Officer (Medical Device) in Charlotte, NC!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
