Are you an expert in regulatory strategy with a deep understanding of global medical device regulations? We are seeking a Vice President of Regulatory Affairs (Medical Device) in Denver, CO to lead the company’s regulatory strategy, ensuring compliance with FDA, EU MDR, and other international regulations. This executive role requires an experienced leader who can oversee regulatory submissions, interact with government agencies, and develop policies that align with evolving industry standards. If you have a strong background in medical device regulatory affairs and are passionate about bringing innovative healthcare solutions to market, this is an opportunity to make a significant impact.
About This Role
As the Vice President of Regulatory Affairs (Medical Device) in Denver, CO, you will be responsible for shaping the company’s global regulatory strategy, ensuring compliance, and driving successful product approvals. You will work closely with cross-functional teams, including R&D, quality assurance, and legal, to ensure smooth regulatory pathways for new and existing medical devices. The ideal candidate will have extensive experience with FDA and international regulatory bodies, strong leadership skills, and the ability to influence regulatory policies. This role offers the chance to lead a high-performing team and play a key role in the company’s growth and innovation.
Key Responsibilities – Vice President of Regulatory Affairs (Medical Device) in Denver, CO
Develop and Execute Global Regulatory Strategy
- Define and implement regulatory strategies to support product development and commercialization.
- Ensure compliance with FDA, EU MDR, and other global regulatory requirements.
- Stay ahead of evolving regulations and proactively adjust company policies.
Oversee Regulatory Submissions and Approvals
- Lead the preparation and submission of 510(k), PMA, IDE, and other regulatory filings.
- Manage responses to regulatory agency inquiries and ensure timely approvals.
- Develop submission strategies to minimize approval timelines and maximize market entry opportunities.
Liaise with Regulatory Agencies and Industry Groups
- Establish and maintain strong relationships with the FDA, EMA, and other international regulatory authorities.
- Represent the company in industry associations and regulatory meetings.
- Advocate for regulatory policies that support business objectives and patient safety.
Ensure Post-Market Compliance and Surveillance
- Oversee post-market surveillance programs, including adverse event reporting and complaint handling.
- Implement risk management strategies to ensure ongoing compliance.
- Ensure the company meets all post-market regulatory requirements.
Collaborate with R&D and Quality Teams
- Work closely with R&D to align regulatory strategies with product development goals.
- Partner with quality assurance to maintain compliance with ISO 13485 and GMP standards.
- Provide regulatory guidance throughout the product lifecycle.
Manage Regulatory Team and Drive Excellence
- Lead and mentor a team of regulatory professionals, ensuring high performance.
- Develop training programs to enhance regulatory knowledge across the organization.
- Foster a culture of compliance, innovation, and continuous improvement.
Support Business Expansion and Market Entry
- Assess regulatory requirements for entering new international markets.
- Develop strategies to streamline the registration and approval process in key global regions.
- Guide the business in expanding its global regulatory footprint.
Monitor Regulatory Trends and Competitor Activity
- Track emerging regulatory trends and assess their impact on the business.
- Analyze competitor regulatory strategies to identify best practices.
- Provide insights to executive leadership to inform business decisions.
What The Client is Looking For in You
To excel as the Vice President of Regulatory Affairs (Medical Device) in Denver, CO, you must be a strategic leader with deep expertise in global medical device regulations. The ideal candidate should bring:
- Extensive Regulatory Affairs Expertise – A proven track record in leading regulatory strategies, managing submissions, and securing approvals for medical devices in global markets, including FDA (510(k), PMA, IDE), EU MDR, and other international regulatory pathways.
- Strong Leadership & Team Development – Experience in building, mentoring, and managing high-performing regulatory teams, fostering a culture of compliance, collaboration, and continuous improvement.
- Strategic & Analytical Thinking – The ability to assess evolving regulations, develop proactive strategies, and align regulatory goals with business objectives.
- Hands-on Experience with Regulatory Agencies – Direct engagement with the FDA, EMA, and other regulatory bodies, including handling audits, negotiations, and responses to inquiries.
- Expertise in Post-Market Compliance – A deep understanding of post-market surveillance, risk management, adverse event reporting, and regulatory compliance for existing products.
- Cross-Functional Collaboration Skills – The ability to work closely with R&D, quality assurance, legal, and executive teams to ensure regulatory requirements are integrated into product development and business strategy.
- Knowledge of Emerging Regulatory Trends – Staying ahead of regulatory changes, industry best practices, and competitor activities to keep the company at the forefront of compliance and innovation.
- Global Market Expansion Capabilities – Experience with international regulatory requirements, including those in Europe, Asia, and Latin America, to support market entry and business growth.
Why This Opportunity Stands Out
This role presents an exciting opportunity for an experienced regulatory affairs leader to drive impactful change within a growing medical device company. As the Vice President of Regulatory Affairs (Medical Device) in Denver, CO, you will:
- Lead Global Regulatory Strategy – Shape and execute regulatory strategies that will drive the company’s expansion into new markets and ensure compliance with evolving medical device regulations.
- Be at the Forefront of Innovation – Work with cutting-edge medical technologies that improve patient outcomes and healthcare solutions worldwide.
- Engage with Regulatory Agencies and Influence Policies – Represent the company in high-level regulatory discussions, shaping the future of compliance within the medical device industry.
- Work with a High-Performing Leadership Team – Collaborate with senior executives, R&D, and quality teams to align regulatory strategies with business objectives and market goals.
- Enjoy Competitive Compensation & Executive Perks – Benefit from a lucrative salary, performance-based incentives, stock options, and executive-level benefits.
- Make a Global Impact – Lead the company’s regulatory affairs efforts to bring life-changing medical devices to patients across the world.
- Advance Your Career in a Growing Organization – Play a pivotal role in scaling a medical device company that values regulatory excellence, compliance, and strategic leadership.
FAQs About the Role
Q: What industries should I have experience in?
A: You should have extensive experience in regulatory affairs within the medical device industry, particularly in handling FDA submissions, EU MDR compliance, and international regulatory approvals.
Q: Is relocation required for this position?
A: The role is based in Denver, CO. Candidates must either be local or willing to relocate. A relocation package may be available for the right candidate.
Q: What is the reporting structure for this role?
A: The Vice President of Regulatory Affairs (Medical Device) in Denver, CO will report directly to the Chief Executive Officer (CEO) and collaborate closely with R&D, quality, and legal teams.
Q: What kind of leadership style is expected?
A: The ideal candidate should be a strategic, hands-on leader who can guide teams, navigate complex regulatory challenges, and drive regulatory excellence across the organization.
Q: What is the expected travel requirement?
A: Some travel will be required for regulatory meetings, industry conferences, and interactions with global regulatory agencies. However, most responsibilities will be based in Denver, CO.
Q: What qualifications and skills are required?
A: Candidates should have a bachelor’s or master’s degree in regulatory affairs, life sciences, engineering, or a related field, along with 10+ years of leadership experience in medical device regulatory affairs. RAC (Regulatory Affairs Certification) is a plus.
Q: How does this role contribute to the company’s success?
A: The Vice President of Regulatory Affairs (Medical Device) in Denver, CO will play a crucial role in securing product approvals, ensuring compliance, and guiding the company’s regulatory strategy to support business growth and innovation.
Q: What is the timeline for hiring and onboarding?
A: The company aims to fill this role within the next 60–90 days. Onboarding will include strategy meetings, regulatory assessments, and cross-functional collaboration to align regulatory goals with business objectives.
What Remuneration Can You Expect from This Job?
As the Vice President of Regulatory Affairs (Medical Device) in Denver, CO, you can expect a highly competitive compensation package that reflects your leadership expertise and regulatory experience. The base salary for this executive role ranges between $190,000 and $260,000 per year, depending on qualifications, regulatory track record, and global market expertise.
In addition to the base salary, this position includes a performance-based bonus structure tied to successful regulatory submissions, product approvals, and compliance milestones. Top performers could achieve total annual earnings exceeding $300,000 with bonuses and incentives.
Other executive benefits include:
- Equity or stock options based on company performance and long-term strategic impact
- Comprehensive health, dental, and vision insurance with executive-level coverage
- 401(k) with company matching to support long-term financial security
- Relocation assistance for qualified candidates willing to move to Denver, CO
- Paid executive travel for regulatory meetings, industry events, and compliance conferences
- Professional development opportunities, including RAC certification sponsorship and leadership training
This role offers exceptional earning potential, a chance to shape regulatory strategy, and the opportunity to drive compliance success for a leading medical device company.
How to Apply for This Vice President of Regulatory Affairs (Medical Device) Position in Denver, CO
If you are a strategic regulatory leader with a proven track record in medical device compliance and approvals, we invite you to apply for the Vice President of Regulatory Affairs (Medical Device) in Denver, CO. This is an outstanding opportunity to lead regulatory strategies, ensure global compliance, and shape the future of medical device innovation.
To apply, submit your resume and a cover letter detailing your experience in regulatory affairs, FDA and global approvals, and leadership in medical device compliance.
This position offers an opportunity to drive regulatory excellence, work with groundbreaking medical technologies, and make a lasting impact in the healthcare industry. Apply today to take the next step in your executive career as a Vice President of Regulatory Affairs (Medical Device) in Denver, CO!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags:
Vice President of Regulatory Affairs | Medical Device Compliance | FDA Regulatory Leadership | Global Regulatory Strategy | Healthcare Regulations
