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Director Innovation Medical Devices Jobs (NOW HIRING)

... medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across ... As Associate Director, Innovation, you will partner with leaders across AbbVie to optimize the ...

... medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across ... As Associate Director, Innovation, you will partner with leaders across AbbVie to optimize the ...

$150 - $200/hr

The Director, Innovation Services supports all of KU including the KU Medical Center in Kansas City, the KU Center for Technology Commercialization (KUCTC) seeks to manage discoveries and innovations ...

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Director Innovation Medical Devices information

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$13K

$232.4K

$357K

How much do director innovation medical devices jobs pay per year?

As of Sep 9, 2026, the average yearly pay for director innovation medical devices in the United States is $232,369.00, according to ZipRecruiter salary data. Most workers in this role earn between $198,000.00 and $284,500.00 per year, depending on experience, location, and employer.

What does a director innovation medical devices do?

A Director of Innovation in Medical Devices leads the development and implementation of new technologies and products within the medical device industry. They oversee research teams, manage projects from concept to commercialization, and ensure that innovations meet regulatory requirements and market needs. This role often involves collaborating with cross-functional teams, identifying opportunities for growth, and staying ahead of industry trends to drive business success.

How does a director innovation medical devices typically collaborate with cross-functional teams to drive product development?

As a Director of Innovation in Medical Devices, you will frequently work with cross-functional teams including R&D, regulatory affairs, marketing, and clinical specialists. Collaboration often involves leading brainstorming sessions, aligning product concepts with regulatory requirements, and ensuring that prototypes meet both clinical needs and business goals. Regular communication and stakeholder engagement are essential for overcoming challenges such as balancing innovation with compliance and navigating the complexities of the medical device approval process. This collaborative approach not only accelerates product development but also helps ensure successful market launches.

What are the key skills and qualifications needed to thrive as a director innovation medical devices?

To thrive as a Director of Innovation in Medical Devices, you need advanced expertise in biomedical engineering, product development, regulatory compliance, and a relevant degree (often a master's or PhD) with significant industry experience. Familiarity with regulatory frameworks (such as FDA or CE), project management tools, and innovation methodologies (like Design Thinking) is essential. Strong leadership, strategic vision, and the ability to foster cross-functional collaboration are standout soft skills in this role. These competencies are critical for successfully guiding teams to develop safe, effective, and market-leading medical devices in a highly regulated environment.

What are popular job titles related to Director Innovation Medical Devices jobs?

For Director Innovation Medical Devices jobs, the most frequently searched job titles are:

Infographic showing various Director Innovation Medical Devices job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $232,369 per year, or $111.7 per hour.

Director, Regulatory Affairs (Medical Devices)

Denver, CO โ€ข On-site

System One
Business Consulting Servicesย โ€ขย 5 - 10K employees

$195K - $245K/yr

Other

Re-posted 23 days ago


Job description

Director, Regulatory Affairs (Medical Devices) Medical Device | Global Scope | Denver Metro (Hybrid) Compensation: $195,000–$245,000 base + 30% target bonus (Compensation aligned to experience, scope, and market benchmarks.) The Opportunity A well-established and growth-oriented medical device organization is seeking a strategic regulatory leader to guide global regulatory affairs and labeling strategy across a diverse product portfolio. This role offers the opportunity to shape regulatory direction at the executive level while driving product approvals, lifecycle management, and global compliance initiatives. This is a highly visible leadership position supporting innovation from early development through commercialization and post-market compliance. Location Requirement: Candidates must reside in the Denver metro area to support a hybrid work model.
What You’ll Lead
  • Define and execute global regulatory strategy aligned to business objectives.
  • Provide executive-level regulatory guidance for new product introductions and existing commercial portfolios.
  • Oversee global labeling strategy and ensure alignment with evolving regulatory standards.
  • Serve as the primary liaison to regulatory authorities worldwide.
  • Direct major submissions including 510(k), PMA, IDE, CE Mark technical documentation, and applicable pharmaceutical filings (NDA/ANDA).
  • Champion compliance programs including UDI, state licensing, regulatory operations, and broader quality initiatives.
  • Anticipate regulatory risks and proactively develop mitigation strategies.
  • Guide cross-functional teams across R&D, Clinical, Quality, Legal, Manufacturing, and Commercial.
  • Represent regulatory strategy at management reviews and executive forums.
  • Lead, mentor, and develop a high-performing regulatory team.
  • Monitor global regulatory trends and participate in industry engagement to proactively influence change.
Ideal Background We’re seeking a regulatory executive who combines strategic vision with operational depth. Required Experience:
  • 10+ years of progressive regulatory affairs experience within medical devices (combination product experience strongly preferred).
  • Demonstrated success leading global regulatory submissions and securing approvals for complex technologies.
  • Experience interacting directly with regulatory agencies in the U.S. and internationally.
  • Strong background in global labeling oversight.
  • 5+ years of people leadership experience, including managing senior-level professionals.
  • Expertise in regulatory compliance across U.S., EU, Canada, and other international markets.
Preferred Experience:
  • Experience with sterile disposables and/or electro-mechanical devices with embedded software.
  • Exposure to drug/device combination products.
  • Experience collaborating closely with clinical teams throughout trial phases.
  • Background supporting or partnering closely with Quality Management Systems.
  • Regulatory certification (e.g., RAC) is a plus.
Leadership Profile Successful candidates will demonstrate:
  • Executive-level strategic thinking with the ability to translate complex regulations into practical business solutions.
  • Confidence representing innovative technologies before regulatory bodies.
  • Strong influence skills across senior leadership and cross-functional stakeholders.
  • The ability to build a culture of quality and regulatory excellence.
  • Comfort operating in environments where regulatory pathways may require creative and forward-thinking strategy.
Additional Details
  • Hybrid schedule (Denver metro required).
  • 10–15% international travel.
  • Occasional off-hours engagement consistent with executive-level responsibilities.
Ref: #568-Clinical


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About System One

Sourced by ZipRecruiter

System One helps employers get work done more efficiently and economically without compromising quality. Over our 35+ year history, we've helped connect thousands of talented people with innovative companies. The excitement of a perfect fit motivates us every single day.

Industry

Business consulting services and recruiting and staffing services

Company size

5,001 - 10,000 Employees

Headquarters location

Pittsburgh, PA, US