Director of Quality and Regulatory Affairs

Job overview

The Director of Quality and Regulatory Affairs role is onsite in Denver, CO; compensation is not specified. MRINetwork Jobs is presenting a role focused on regulatory affairs, compliance systems, and labeling for a business area or region. The director sets regulatory and labeling strategy, leads compliance programs, oversees regulatory submissions, and serves as an interface with regulatory bodies. The role works across senior leadership and functions including R&D, clinical, quality, legal, manufacturing, and marketing to support product development and maintain regulatory compliance.

What you'll do

• Provide strategic and operational leadership for regulatory affairs and global labeling
• develop regulatory strategies and compliance programs
• oversee regulatory submissions including 510(k), IDE, PMA, CE technical files, NDA, and ANDA submissions
• interface with regulatory bodies
• direct staff development and supervision
• support product development and design validation
• maintain quality management system effectiveness with Quality Assurance
• identify and mitigate regulatory and compliance risks.

What we're looking for

Skills & competencies

director

regulatory affairs

quality

compliance systems

global labeling

medical devices

pharmaceuticals

regulatory submissions

denver co

mrinetwork jobs

Work arrangement

• Weekend coverage required

Why this role

The posting requires a four-year college degree, at least 10 years of regulatory experience in medical devices or pharmaceuticals, and at least five years of managerial experience.

About the employer

MRINetwork Jobs is hiring for this role. Industry: All Other Professional, Scientific, and Technical Services. Sector: 54.