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Director Regulatory Operations Jobs in Colorado (NOW HIRING)

Morgan Stanley

Director, Regulatory Affairs

Littleton, CO · On-site

$177 - $266/hr

Working closely with executive leadership and cross‑functional teams, you will drive regulatory excellence while supporting business growth, product innovation, and operational success. Based at ...

3D Systems

Director, Regulatory Affairs

Centennial, CO · On-site

$177K - $266K/yr

... operational success. Based at our U.S. healthcare headquarters in Littleton, Colorado, this role ... What You Will Do Lead Global Regulatory Strategy Define and execute global regulatory strategies ...

3D Systems

Director, Regulatory Affairs

Centennial, CO · On-site

$177K - $266K/yr

... operational success. Based at our U.S. healthcare headquarters in Littleton, Colorado, this role ... What You Will Do Lead Global Regulatory Strategy Define and execute global regulatory strategies ...

3D Systems, Inc.

Director, Regulatory Affairs

Littleton, CO · On-site

$177K - $266K/yr

Working closely with executive leadership and cross-functional teams, you will drive regulatory excellence while supporting business growth, product innovation, and operational success. Based at our ...

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Director Regulatory Operations information

See Colorado salary details

$35.8K

$113.2K

$188.7K

How much do director regulatory operations jobs pay per year?

As of Aug 29, 2026, the average yearly pay for director regulatory operations in Colorado is $113,228.00, according to ZipRecruiter salary data. Most workers in this role earn between $79,400.00 and $142,500.00 per year, depending on experience, location, and employer.

What does a director regulatory operations do?

A Director of Regulatory Operations oversees the development, submission, and management of regulatory documents to ensure compliance with industry regulations. They lead regulatory teams, streamline processes, and collaborate with internal stakeholders to meet regulatory requirements efficiently. Their responsibilities often include managing electronic submissions, maintaining regulatory information systems, and staying updated on changing regulatory guidelines.

What are the typical responsibilities and team dynamics for a director regulatory operations?

As a Director Regulatory Operations, your primary responsibilities include overseeing the preparation and submission of regulatory documents, ensuring compliance with global standards, and leading process improvement initiatives. You will usually manage a team of regulatory professionals and collaborate closely with clinical, quality, and legal departments to align regulatory strategies with business goals. The role often involves managing multiple projects simultaneously, tracking submission timelines, and anticipating regulatory challenges. This is a fast-paced position offering leadership opportunities and the potential to advance to executive roles within regulatory affairs or related departments.

What are the key skills and qualifications needed to thrive in the director regulatory operations position, and why are they important?

To excel as a Director Regulatory Operations, you need comprehensive knowledge of regulatory affairs, quality systems, and project management, usually supported by an advanced degree in life sciences or a related field. Familiarity with regulatory submission systems (such as eCTD), document management platforms, and certifications like RAC (Regulatory Affairs Certification) are commonly required. Outstanding organizational skills, strategic leadership, and the ability to communicate and negotiate effectively are essential soft skills. These competencies ensure efficient regulatory compliance, timely submissions, and effective coordination across cross-functional teams in a highly regulated environment.

What are the most commonly searched types of Regulatory Operations jobs in Colorado?

The most popular types of Regulatory Operations jobs in Colorado are:

What are popular job titles related to Director Regulatory Operations jobs in Colorado?

For Director Regulatory Operations jobs in Colorado, the most frequently searched job titles are:

What job categories do people searching Director Regulatory Operations jobs in Colorado look for?

The top searched job categories for Director Regulatory Operations jobs in Colorado are:

What cities in Colorado are hiring for Director Regulatory Operations jobs?

Cities in Colorado with the most Director Regulatory Operations job openings:

Director Regulatory Operations jobs near you
Infographic showing various Director Regulatory Operations job openings in Colorado as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $113,228 per year, or $54.4 per hour.

Director, Regulatory Affairs (Medical Devices)

Denver, CO • On-site

System One
Business Consulting Services • 5 - 10K employees
Learn more about System Oneexternal

$195K - $245K/yr

Other

Re-posted 12 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

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