Are you a regulatory expert with a deep understanding of global medical device regulations? We are seeking a Director of Regulatory Intelligence (Medical Device) in Denver, CO, to lead the development and implementation of regulatory strategies that ensure compliance while driving innovation. This executive-level role requires a visionary leader who can navigate the complex and evolving regulatory landscape, providing actionable insights to support business growth and product development.
As the Director of Regulatory Intelligence (Medical Device) in Denver, CO, you will play a pivotal role in analyzing regulatory trends, shaping compliance frameworks, and advising leadership on global regulatory changes. This position is ideal for a strategic thinker with extensive experience in FDA, EU MDR, and international regulatory policies. If you excel in transforming regulatory intelligence into strategic business opportunities, we want to hear from you.
About This Role
The Director of Regulatory Intelligence (Medical Device) in Denver, CO, will be responsible for monitoring and interpreting global regulatory developments, assessing their impact on the company’s product portfolio, and ensuring proactive compliance. This role involves collaborating with cross-functional teams, providing regulatory guidance, and shaping corporate regulatory policies. You will oversee risk assessments, contribute to regulatory submissions, and drive strategic initiatives to maintain the company’s competitive edge in the medical device industry.
This position requires a detail-oriented leader who can anticipate regulatory shifts, engage with industry stakeholders, and advocate for regulatory best practices. The Director of Regulatory Intelligence (Medical Device) in Denver, CO, will work closely with legal, clinical, and product development teams to ensure compliance while enabling business success. If you thrive in a dynamic environment where regulatory expertise meets strategic leadership, this role offers an exciting career opportunity.
Key Responsibilities – Director of Regulatory Intelligence (Medical Device) in Denver, CO
Monitor and Analyze Global Regulatory Trends
- Track changes in FDA, EU MDR, ISO, and other international medical device regulations.
- Assess the impact of regulatory developments on existing and future product lines.
- Provide leadership with timely updates and recommendations for compliance strategies.
Develop and Implement Regulatory Intelligence Frameworks
- Establish systems to collect, analyze, and disseminate regulatory intelligence across departments.
- Collaborate with cross-functional teams to align regulatory insights with business objectives.
- Create regulatory roadmaps to proactively address compliance challenges and opportunities.
Lead Regulatory Policy Development and Advocacy
- Shape internal regulatory policies to ensure alignment with global best practices.
- Represent the company in industry associations, working groups, and regulatory forums.
- Advocate for regulatory changes that support innovation and business growth.
Support Regulatory Submissions and Compliance Strategies
- Provide insights to regulatory affairs teams on submission requirements and best practices.
- Assist in preparing responses to regulatory agencies and audits.
- Ensure that regulatory intelligence is effectively integrated into product development and lifecycle management.
Conduct Risk Assessments and Mitigation Planning
- Identify potential regulatory risks and develop proactive mitigation strategies.
- Support compliance teams in evaluating regulatory gaps and implementing corrective actions.
- Provide strategic guidance on risk-benefit analysis for new market entries.
Engage with Regulatory Agencies and Industry Experts
- Build and maintain strong relationships with FDA, EMA, and other regulatory bodies.
- Participate in discussions with regulatory authorities to clarify compliance expectations.
- Stay informed on industry trends by networking with regulatory professionals and thought leaders.
Train and Educate Internal Teams on Regulatory Matters
- Develop training programs to enhance regulatory awareness across departments.
- Guide R&D, clinical, and quality teams on evolving regulatory requirements.
- Ensure cross-functional teams are equipped with the latest regulatory knowledge.
Drive Innovation While Ensuring Regulatory Compliance
- Collaborate with product development teams to balance innovation with compliance.
- Identify opportunities to leverage regulatory pathways for faster market entry.
- Support business growth by integrating regulatory intelligence into corporate strategy.
What The Client is Looking For in You
To excel as the Director of Regulatory Intelligence (Medical Device) in Denver, CO, you should bring a blend of regulatory expertise, strategic leadership, and the ability to interpret complex regulations in a way that drives business success. The ideal candidate will possess:
- Extensive Regulatory Knowledge – A deep understanding of FDA, EU MDR, ISO 13485, and international regulatory frameworks governing medical devices. Experience with post-market surveillance, clinical evaluations, and quality management systems is a plus.
- Proven Experience in Regulatory Intelligence – Demonstrated success in monitoring global regulatory changes and translating them into actionable business strategies.
- Strategic and Analytical Thinking – The ability to assess regulatory risks, develop compliance strategies, and align regulatory insights with corporate objectives.
- Strong Leadership and Communication Skills – Experience leading cross-functional teams, educating stakeholders on regulatory matters, and engaging with regulatory authorities.
- Regulatory Advocacy Experience – A history of participating in industry associations, working groups, or advisory panels to influence regulatory policies.
- Attention to Detail and Risk Assessment Expertise – The ability to identify regulatory risks, evaluate compliance gaps, and implement mitigation strategies.
- Experience in Medical Device Product Development – Familiarity with product lifecycle management, regulatory submissions, and market entry strategies.
- Ability to Balance Compliance with Innovation – A proactive approach to ensuring regulatory adherence while enabling business growth and technological advancements.
If you thrive in a fast-paced environment where your regulatory expertise shapes the future of medical device innovation, this role is the perfect fit.
Why This Opportunity Stands Out
This role offers a unique opportunity to be at the forefront of regulatory intelligence in the medical device industry. As the Director of Regulatory Intelligence (Medical Device) in Denver, CO, you will:
- Lead Regulatory Strategy for a Growing Company – Play a key role in shaping the company’s regulatory policies and ensuring compliance with global regulations.
- Be a Trusted Advisor to Executive Leadership – Influence critical business decisions by providing expert regulatory insights.
- Competitive Compensation & Benefits – Enjoy a lucrative salary, performance incentives, and a comprehensive benefits package.
- Work in a Highly Innovative and Collaborative Environment – Join a team dedicated to developing groundbreaking medical technologies while maintaining compliance.
- Impact the Future of Healthcare – Help ensure that life-saving medical devices reach patients worldwide through efficient and compliant regulatory pathways.
- Engage with Industry Leaders and Regulatory Agencies – Build relationships with key regulatory bodies and stay ahead of global regulatory trends.
- Opportunity for Professional Growth – Expand your expertise in regulatory intelligence while contributing to the company’s long-term success.
This is an unparalleled opportunity to make a significant impact in the medical device sector while growing your career in regulatory intelligence.
FAQs About the Role
Q: What industries should I have experience in?
A: You should have a strong background in the medical device industry, with expertise in regulatory affairs, compliance, and product lifecycle management.
Q: Is relocation required for this position?
A: The role is based in Denver, CO. Candidates must be open to relocation or already reside in the area.
Q: What is the reporting structure for this role?
A: The Director of Regulatory Intelligence (Medical Device) in Denver, CO will report directly to the Vice President of Regulatory Affairs and collaborate closely with legal, clinical, and product development teams.
Q: What kind of leadership style is expected?
A: We seek a detail-oriented, strategic, and proactive leader who can work cross-functionally, provide clear regulatory guidance, and drive compliance initiatives.
Q: What is the expected travel requirement?
A: This role may require occasional domestic and international travel for industry conferences, regulatory meetings, and strategic planning sessions.
Q: What qualifications and skills are required?
A: Candidates should have a bachelor’s or master’s degree in regulatory affairs, biomedical engineering, or a related field, along with 10+ years of experience in medical device regulatory intelligence or compliance.
Q: How does this role contribute to the company’s overall success?
A: The Director of Regulatory Intelligence (Medical Device) in Denver, CO ensures that the company remains compliant while proactively navigating regulatory changes to support business growth and innovation.
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 the next 60–90 days. Onboarding will include strategy sessions with leadership and integration into regulatory operations.
What Remuneration Can You Expect from This Job?
As the Director of Regulatory Intelligence (Medical Device) in Denver, CO, you can expect a highly competitive compensation package that reflects your expertise in regulatory affairs and intelligence. The base salary for this executive-level role typically ranges between $180,000 – $240,000 per year, depending on experience, industry knowledge, and past success in regulatory compliance and strategy.
In addition to the base salary, this position offers performance-based bonuses linked to key regulatory milestones, successful submissions, and compliance achievements. For the right candidate, equity options or stock grants may be included, 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 opportunities such as attending global regulatory conferences and workshops. Additional perks may include relocation assistance, travel allowances, and access to executive leadership training programs.
This role not only offers an attractive financial package but also the opportunity to play a critical role in shaping regulatory strategies for an innovative medical device company. If you are a regulatory expert seeking a leadership role with strong growth potential, this opportunity is ideal for you.
How to Apply for This Director of Regulatory Intelligence (Medical Device) Position in Denver, CO
If you are a seasoned regulatory professional with a strong background in global medical device regulations, compliance strategy, and regulatory intelligence, we invite you to apply for the Director of Regulatory Intelligence (Medical Device) in Denver, CO. This is an exceptional opportunity to lead regulatory initiatives, ensure compliance, and drive business success through regulatory foresight.
To apply, please submit your resume and a cover letter detailing your experience in regulatory affairs, global compliance, and industry advocacy within the medical device sector.
This role offers a unique chance to work alongside top industry experts, develop innovative regulatory strategies, and contribute to a company that is shaping the future of medical device technology. Apply today to take the next step in your career as the Director of Regulatory Intelligence (Medical Device) in Denver, CO!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags:
Director of Regulatory Intelligence | Medical Device Compliance | Regulatory Affairs Executive | Global Regulatory Strategy | FDA Compliance | ISO 13485
