Are you an expert in regulatory affairs with a deep understanding of FDA, ISO, and global compliance standards? We are seeking a Director of Regulatory Compliance (Medical Device) in Miami, FL, to lead the regulatory strategy and ensure compliance with evolving industry regulations. This role is ideal for a professional with extensive experience in medical device regulatory affairs, risk management, and quality assurance.
As the Director of Regulatory Compliance (Medical Device) in Miami, FL, you will oversee regulatory submissions, manage compliance programs, and collaborate with cross-functional teams to maintain regulatory excellence. Your expertise in navigating complex regulatory frameworks will be instrumental in bringing innovative medical devices to market while ensuring patient safety and product efficacy. If you are passionate about regulatory leadership and want to make a significant impact in the medical device sector, this opportunity is for you.
About This Role
The Director of Regulatory Compliance (Medical Device) in Miami, FL, plays a crucial role in ensuring that all medical device products meet regulatory standards and maintain compliance with national and international laws. This position requires a strategic leader with experience in regulatory filings, product approvals, and post-market surveillance. The ideal candidate will develop and implement regulatory strategies that align with business objectives while ensuring adherence to FDA, EU MDR, ISO 13485, and other relevant regulations.
In this role, you will work closely with R&D, manufacturing, and quality teams to ensure seamless regulatory submissions and ongoing compliance. You will also be responsible for monitoring changes in global regulatory requirements, assessing potential risks, and ensuring that company policies remain up to date. With a focus on maintaining the highest compliance standards, the Director of Regulatory Compliance (Medical Device) in Miami, FL, will drive regulatory excellence and contribute to the successful commercialization of innovative medical technologies.
Key Responsibilities – Director of Regulatory Compliance (Medical Device) in Miami, FL
1. Develop and Implement Regulatory Strategies
- Design and execute comprehensive regulatory strategies to ensure compliance with FDA, EU MDR, and other global regulatory bodies.
- Work closely with product development teams to provide regulatory guidance throughout the product lifecycle.
- Ensure that regulatory plans align with business objectives while meeting legal requirements.
2. Oversee Regulatory Submissions and Approvals
- Lead the preparation and submission of regulatory filings, including 510(k), PMA, CE Mark, and international approvals.
- Manage interactions with regulatory agencies, including FDA, EMA, and other health authorities.
- Ensure timely approvals and clearances by addressing regulatory inquiries and deficiencies efficiently.
3. Ensure Compliance with Industry Regulations and Standards
- Maintain up-to-date knowledge of regulatory requirements, including ISO 13485, FDA QSR, and EU MDR.
- Implement policies and procedures to ensure ongoing compliance with changing regulatory landscapes.
- Conduct internal audits and gap assessments to identify areas for improvement.
4. Lead Post-Market Compliance and Surveillance
- Develop and oversee post-market surveillance programs, including complaint handling and adverse event reporting.
- Monitor product safety and effectiveness to ensure continued regulatory compliance.
- Implement corrective and preventive actions (CAPA) to address compliance issues.
5. Collaborate with Cross-Functional Teams
- Work closely with R&D, manufacturing, and quality teams to integrate regulatory requirements into product development.
- Provide regulatory training and guidance to internal teams to ensure a culture of compliance.
- Act as the regulatory liaison between the company and external stakeholders, including notified bodies and government agencies.
6. Manage Quality Systems and Risk Assessment
- Oversee the implementation and maintenance of the company’s quality management system (QMS).
- Conduct risk assessments to identify and mitigate potential regulatory and compliance risks.
- Ensure effective documentation and record-keeping practices to support compliance efforts.
7. Drive Regulatory Intelligence and Continuous Improvement
- Stay informed about industry trends, regulatory changes, and emerging best practices.
- Develop strategies to proactively address evolving regulatory requirements.
- Lead initiatives to enhance the company’s regulatory capabilities and streamline compliance processes.
8. Represent the Company in Regulatory Matters
- Serve as the primary point of contact for regulatory agencies, industry groups, and compliance organizations.
- Participate in regulatory meetings, industry conferences, and working groups to advocate for company interests.
- Build strong relationships with external regulatory bodies to facilitate smooth product approvals and compliance initiatives.
What The Client is Looking For in You
To excel as the Director of Regulatory Compliance (Medical Device) in Miami, FL, you should bring a combination of regulatory expertise, strategic leadership, and an in-depth understanding of medical device compliance requirements. The ideal candidate will possess:
- Extensive Experience in Medical Device Regulatory Affairs – A strong background in regulatory compliance, including experience with FDA 510(k), PMA, CE Mark, ISO 13485, EU MDR, and international submissions.
- Proven Success in Regulatory Submissions and Approvals – A track record of successfully leading regulatory filings and obtaining market approvals for medical devices in the U.S. and global markets.
- Strong Leadership and Team Collaboration – Experience working cross-functionally with R&D, quality assurance, legal, and manufacturing teams to ensure seamless regulatory compliance throughout the product lifecycle.
- Analytical and Strategic Thinking – The ability to assess complex regulatory challenges, identify risks, and develop proactive strategies to navigate compliance requirements.
- Up-to-Date Knowledge of Evolving Regulations – A deep understanding of the latest changes in global medical device regulations, with the ability to adapt company policies accordingly.
- Excellent Communication and Regulatory Negotiation Skills – The ability to interface with regulatory agencies, notified bodies, and internal stakeholders effectively to streamline approval processes.
- Attention to Detail and Strong Documentation Practices – A meticulous approach to maintaining regulatory records, preparing compliance reports, and ensuring audit readiness.
- A Passion for Patient Safety and Innovation – A commitment to ensuring that all medical device products meet the highest safety and compliance standards while driving innovation in the industry.
Why This Opportunity Stands Out
This role offers a unique opportunity to lead regulatory compliance for a growing medical device company that is dedicated to innovation and global market expansion. As the Director of Regulatory Compliance (Medical Device) in Miami, FL, you will:
- Be a Key Compliance Leader – Play a critical role in ensuring that groundbreaking medical technologies meet the highest regulatory standards and reach global markets.
- Work with Cutting-Edge Medical Devices – Contribute to the development and commercialization of innovative medical devices that improve patient care.
- Competitive Compensation & Executive Benefits – Enjoy a highly competitive salary, performance-based bonuses, and a comprehensive benefits package.
- Directly Impact Business Success – Drive regulatory strategies that shape the company’s commercial success and compliance framework.
- Opportunities for Career Growth – Be part of a fast-growing company with leadership opportunities and career advancement potential.
- Collaborate with Industry Experts – Work alongside top professionals in the medical device industry, including regulatory specialists, R&D engineers, and executive leadership.
- Engage with Global Regulatory Bodies – Gain hands-on experience in international compliance, working with regulatory agencies worldwide.
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, regulatory affairs, or quality management. Experience with FDA, EU MDR, and ISO 13485 regulations is essential.
Q: Is relocation required for this position?
A: This role is based in Miami, FL. Candidates must be open to relocation or already reside in the area. Some remote flexibility may be considered for highly qualified candidates.
Q: What kind of leadership style is expected?
A: The ideal candidate should be a proactive leader who can collaborate with cross-functional teams, mentor regulatory staff, and drive a strong culture of compliance and innovation.
Q: What is the expected travel requirement?
A: Some domestic and international travel may be required for regulatory meetings, audits, and compliance-related activities.
Q: What qualifications and certifications are required?
A: A bachelor’s or master’s degree in regulatory affairs, biomedical engineering, life sciences, or a related field is preferred. RAC (Regulatory Affairs Certification) is a plus.
Q: How does this role contribute to the company’s overall success?
A: The Director of Regulatory Compliance (Medical Device) in Miami, FL ensures that all products meet global regulatory standards, enabling successful market approvals and maintaining compliance across operations.
Q: What is the timeline for hiring and onboarding?
A: The company is actively seeking the right candidate and aims to complete the hiring process within 60–90 days. Onboarding will include training on current regulatory strategies, integration with internal teams, and alignment on key compliance initiatives.
What Remuneration Can You Expect from This Job?
As the Director of Regulatory Compliance (Medical Device) in Miami, FL, you can expect a highly competitive compensation package that reflects your expertise in regulatory affairs and compliance leadership. The base salary for this role typically falls within the range of $180,000 – $230,000 per year, depending on experience, industry knowledge, and proven success in regulatory submissions and approvals.
In addition to the base salary, this position offers performance-based bonuses and incentives tied to key compliance milestones, regulatory approvals, and successful audit outcomes. Equity options or stock grants may also be available, providing an opportunity 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, paid time off, and professional development support, including conference participation and certification reimbursements. Additional perks may include a relocation package, travel allowances, and executive-level benefits.
This role not only provides a lucrative financial package but also the opportunity to lead compliance strategies for innovative medical devices, shaping the regulatory future of a growing organization while contributing to patient safety and global market expansion.
How to Apply for This Director of Regulatory Compliance (Medical Device) Position in Miami, FL
If you are a regulatory expert with a proven track record in medical device compliance, we invite you to apply for the Director of Regulatory Compliance (Medical Device) in Miami, FL. This is an excellent opportunity to lead regulatory strategies, ensure compliance with global regulations, and play a pivotal role in the company’s success.
To apply, please submit your resume and a cover letter detailing your experience in regulatory submissions, FDA compliance, international market approvals, and quality management systems.
This role offers a rewarding opportunity to drive regulatory excellence, navigate global compliance landscapes, and contribute to an organization that is pioneering medical device innovations. Apply today to take the next step in your career as a Director of Regulatory Compliance (Medical Device) in Miami, FL!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags:
Director of Regulatory Compliance | Medical Device Regulatory Affairs | FDA Compliance | Quality Management Systems | Regulatory Leadership | ISO 13485
