Regulatory Affairs Director — Global Submissions & Strategy

HepQuant, LLC; Denver (CO); On-site; USD 90,000 - 110,000; Full time

Job summary

A clinical laboratory is seeking a Regulatory Affairs specialist in Denver, Colorado, with at least 8 years of experience. The role involves preparing documents for regulatory submissions, engaging with FDA and cross-functional teams, and reviewing promotional materials. Ideal candidates should have strong analytical and communication skills, and experience with FDA/EU submissions is essential. RAC Certification is preferred. Join to contribute to innovative blood-based tests that support clinical management.

Qualifications

• Minimum of 8 years’ experience in Regulatory Affairs & Quality.
• RAC Certification preferred.
• Experience preparing FDA and EU product submissions required.
• Strong working knowledge of all U.S. regulations that affect Class III combination drug/devices.

Responsibilities

• Plan and prepare document packages for submission to global regulatory agencies.
• Interact with FDA and/or other regulatory bodies for submissions.
• Engage with cross-functional stakeholders, including Medical Affairs and Quality.
• Responsible for regulatory review of promotional material and product documentation.

Skills

Regulatory Affairs

Quality Assurance

FDA submissions

Technical writing

Analytical thinking

Tools

Microsoft Excel

Microsoft PowerPoint

Microsoft Word

Job description

A clinical laboratory is seeking a Regulatory Affairs specialist in Denver, Colorado, with at least 8 years of experience. The role involves preparing documents for regulatory submissions, engaging with FDA and cross-functional teams, and reviewing promotional materials. Ideal candidates should have strong analytical and communication skills, and experience with FDA/EU submissions is essential. RAC Certification is preferred. Join to contribute to innovative blood-based tests that support clinical management.