Are you an expert in medical device compliance with a strong background in regulatory affairs, quality assurance, and product safety? We are seeking a Director of Product Compliance (Med Device) in Dallas, TX, to lead compliance strategies, ensure regulatory adherence, and oversee risk management across all product lines. This executive role requires a highly analytical and detail-oriented leader who can navigate complex FDA, ISO, and global regulatory requirements while driving a culture of quality and compliance.
As the Director of Product Compliance (Med Device) in Dallas, TX, you will play a pivotal role in ensuring all products meet stringent regulatory and safety standards while working cross-functionally with R&D, manufacturing, and legal teams. If you have a proven track record in medical device compliance, regulatory submissions, and quality systems management, we encourage you to apply for this high-impact leadership role.
About This Role
The Director of Product Compliance (Med Device) in Dallas, TX, will be responsible for establishing and maintaining best-in-class compliance programs to ensure product safety, regulatory adherence, and business continuity. This role requires deep expertise in global medical device regulations, including FDA, ISO 13485, MDR, and other international standards. The ideal candidate will have extensive experience in regulatory submissions, risk management, product audits, and post-market surveillance to uphold the company’s reputation for excellence.
As a Director of Product Compliance (Med Device) in Dallas, TX, you will collaborate with internal teams and external regulatory bodies to ensure all products meet industry standards. Your role will include overseeing compliance training, mitigating regulatory risks, and leading audits to maintain product certifications and approvals. This is an exciting opportunity for a compliance leader to shape the future of medical device safety and compliance in a fast-growing company.
Key Responsibilities – Director of Product Compliance (Med Device) in Dallas, TX
1. Develop and Implement Compliance Strategies
- Establish comprehensive compliance programs aligned with FDA, ISO 13485, MDR, and other global regulations.
- Develop internal policies and SOPs to ensure regulatory and quality compliance across all product lines.
- Continuously monitor and update compliance protocols in response to regulatory changes and industry best practices.
2. Oversee Regulatory Submissions & Product Approvals
- Lead the preparation and submission of 510(k), PMA, CE Mark, and other regulatory filings.
- Ensure all product documentation is accurate, complete, and aligned with regulatory expectations.
- Work closely with regulatory agencies and notified bodies to facilitate product approvals.
3. Manage Risk Assessment & Product Safety
- Conduct risk assessments to identify and mitigate compliance risks associated with medical devices.
- Oversee post-market surveillance activities, including complaint handling, adverse event reporting, and recalls.
- Implement corrective and preventive actions (CAPA) to address product safety concerns.
4. Lead Internal and External Audits
- Develop audit strategies and lead internal quality audits to ensure ongoing regulatory compliance.
- Manage external audits and inspections conducted by FDA, ISO, and other regulatory agencies.
- Address and resolve audit findings, observations, and non-conformities effectively.
5. Ensure Quality System Compliance
- Oversee the implementation and maintenance of ISO 13485-compliant quality management systems (QMS).
- Work with cross-functional teams to align product development with regulatory expectations.
- Continuously improve quality assurance processes to enhance compliance efficiency.
6. Monitor Global Regulatory Trends & Compliance Updates
- Stay up to date on evolving regulatory requirements, including FDA, MDR, and emerging global standards.
- Implement proactive changes to compliance programs based on evolving industry regulations.
- Provide regulatory insights to senior leadership for strategic decision-making.
7. Provide Compliance Training & Leadership
- Develop and deliver compliance training programs for internal teams, ensuring adherence to regulatory policies.
- Educate cross-functional teams on new regulatory requirements, product safety, and quality assurance.
- Foster a culture of compliance awareness and ethical responsibility throughout the organization.
8. Collaborate with Legal, R&D, and Manufacturing Teams
- Work closely with R&D, engineering, and manufacturing teams to ensure compliance throughout the product lifecycle.
- Provide compliance oversight in product design, labeling, clinical trials, and supply chain operations.
- Partner with legal teams to mitigate regulatory risks and maintain compliance documentation.
What The Client is Looking For in You
To excel as the Director of Product Compliance (Med Device) in Dallas, TX, you need a deep understanding of regulatory compliance, risk management, and quality assurance within the medical device industry. The ideal candidate will have:
- Extensive Experience in Medical Device Compliance – A strong track record of navigating FDA, ISO 13485, MDR, and other global regulations while ensuring product safety and regulatory adherence.
- Proven Expertise in Regulatory Submissions – Hands-on experience in preparing and managing 510(k), PMA, CE Mark, and other regulatory filings to support product approval and market entry.
- Strong Leadership & Team Management Skills – Ability to lead compliance teams, cross-functional groups, and regulatory initiatives while fostering a culture of quality and continuous improvement.
- Strategic & Analytical Thinking – A proactive problem-solver who can anticipate regulatory challenges, mitigate risks, and develop compliance strategies that align with business objectives.
- Experience with Audits & Inspections – Expertise in internal and external audits, including interactions with FDA, notified bodies, and other regulatory agencies.
- Excellent Communication & Collaboration Skills – The ability to work cross-functionally with R&D, legal, and manufacturing teams to ensure compliance is integrated throughout the product lifecycle.
- Detail-Oriented & Process-Driven Approach – Strong documentation skills and a keen eye for regulatory details to ensure all compliance requirements are met.
- Passion for Regulatory Excellence – A commitment to staying ahead of industry trends and ensuring that compliance processes meet the highest standards.
Why This Opportunity Stands Out
This role presents a unique and high-impact leadership opportunity in the medical device industry. As the Director of Product Compliance (Med Device) in Dallas, TX, you will:
- Lead Compliance at a High-Growth Medical Device Company – Work with an innovative company dedicated to advancing medical technology while ensuring patient safety and regulatory excellence.
- Shape the Company’s Regulatory Strategy – Influence the entire compliance framework, from product development to post-market surveillance.
- Competitive Compensation & Executive Perks – Enjoy a highly competitive salary, performance-based bonuses, and an executive-level benefits package.
- Opportunity to Work with Cross-Functional Teams – Engage with R&D, legal, quality assurance, and manufacturing teams to drive regulatory compliance across all aspects of the business.
- Access to Global Markets & Emerging Regulations – Gain exposure to international regulatory frameworks and help bring cutting-edge medical devices to markets worldwide.
- Dynamic & Collaborative Work Culture – Join a forward-thinking company that values innovation, compliance excellence, and leadership development.
- Career Growth & Leadership Development – Build your career in a role that offers long-term advancement opportunities within regulatory and compliance leadership.
FAQs About the Role
Q: What industries should I have experience in?
A: You should have a strong background in medical device compliance, regulatory affairs, and quality assurance with expertise in FDA, ISO 13485, and international medical device regulations.
Q: Is relocation required for this position?
A: The role is based in Dallas, TX. Candidates should be open to relocation or already residing in the area.
Q: What is the reporting structure for this role?
A: The Director of Product Compliance (Med Device) in Dallas, TX will report directly to the VP of Regulatory & Compliance and work closely with R&D, manufacturing, and legal teams.
Q: What kind of leadership style is expected?
A: We seek a strategic, detail-oriented, and proactive leader who can drive compliance initiatives, manage cross-functional teams, and uphold regulatory excellence.
Q: What is the expected travel requirement?
A: This role may require occasional domestic and international travel, particularly for regulatory meetings, audits, and compliance training sessions.
Q: What qualifications and certifications are required?
A: A bachelor’s or master’s degree in Regulatory Affairs, Biomedical Engineering, Quality Assurance, or a related field is required. Certifications such as RAC (Regulatory Affairs Certification) or CQE (Certified Quality Engineer) are preferred.
Q: How does this role contribute to the company’s success?
A: The Director of Product Compliance (Med Device) in Dallas, TX ensures all medical devices meet regulatory requirements, reducing risk, maintaining certifications, and supporting product innovation while ensuring patient safety.
Q: What is the hiring timeline for this role?
A: The company is actively hiring and aims to complete the process within 60–90 days. Onboarding will include training, strategy sessions, and regulatory alignment meetings.
What Remuneration Can You Expect from This Job?
As the Director of Product Compliance (Med Device) in Dallas, TX, you can expect a highly competitive compensation package that reflects your expertise in regulatory compliance, risk management, and quality assurance. The base salary typically ranges from $180,000 to $230,000 per year, depending on your experience, qualifications, and proven success in leading compliance functions within the medical device industry.
Beyond the base salary, this position includes performance-based incentives tied to key regulatory and compliance milestones, such as successful audits, product approvals, and global market expansion. Equity options or long-term incentive plans (LTIPs) may also be available for high-performing candidates.
The benefits package includes comprehensive healthcare coverage (medical, dental, and vision), a 401(k) retirement plan with company matching, executive-level perks, and generous paid time off (PTO). Additional benefits may include relocation assistance, professional development programs, and sponsorship for regulatory certifications like RAC or CQE.
This role offers not only a lucrative financial package but also the opportunity to shape compliance strategies at a leading medical device company while ensuring global regulatory excellence.
How to Apply for This Director of Product Compliance (Med Device) Position in Dallas, TX
If you are a compliance leader with extensive expertise in medical device regulations, quality assurance, and risk management, we invite you to apply for the Director of Product Compliance (Med Device) in Dallas, TX. This is a unique opportunity to lead regulatory strategies, ensure product compliance, and contribute to a company at the forefront of medical technology innovation.
To apply, please submit your resume and a cover letter detailing your experience in regulatory compliance, quality management systems, and risk mitigation within the medical device industry.
This position offers a high-impact leadership role in a rapidly growing organization dedicated to advancing patient safety and regulatory excellence. Apply today to take the next step in your compliance leadership career!
For more information or to explore similar opportunities, visit our Medical Device Jobs Page.
Tags:
Director of Product Compliance | Medical Device Regulatory | Quality Assurance Leadership | FDA Compliance | ISO 13485 | Risk Management |
