Director, Regulatory Affairs

Location: Denver, CO (Hybrid, Relocation Required)

This is a leadership opportunity for a Regulatory Affairs professional to oversee global compliance systems and labeling operations within a growing medical device and biologics-focused organization. The role supports products across their full lifecycle, from development through post-market, with a strong emphasis on global regulatory compliance and operational excellence.

Key Responsibilities:

• Provide strategic and operational leadership for regulatory affairs and global labeling
• Develop and execute regulatory strategies aligned with business objectives across multiple regions
• Oversee global labeling operations, including IFUs, manuals, system documentation, and product variants
• Direct compliance programs such as UDI, state licensing, regulatory operations, and internal assessment programs
• Serve as primary point of contact for regulatory authorities, including inspections and audits (e.g., FDA, MDSAP)
• Identify regulatory and compliance risks and implement cross-functional mitigation strategies
• Partner with R&D, Clinical, Quality, Manufacturing, Legal, and Commercial teams to support product development and commercialization
• Ensure effectiveness of the Quality Management System in line with global regulatory requirements
• Provide strategic input on regulatory submissions (510(k), PMA, CE/MDR, and international filings)
• Act as Person Responsible for Regulatory Compliance (PRRC) where applicable

Leadership and Team Management:

• Lead and develop a global team across labeling, compliance, and regulatory operations
• Manage direct reports and support broader team structure across multiple regions
• Drive a culture of quality and compliance throughout the organization
• Influence senior leadership and participate in business management and planning activities

Qualifications:

• Bachelor's degree required; advanced degree preferred
• 10+ years of regulatory affairs experience in medical device or combination products
• 5+ years of leadership experience managing teams and cross-functional initiatives
• Experience with global regulatory frameworks including U.S., EU, Canada, and other international markets
• Strong background in regulatory compliance, labeling, and quality systems
• Experience with regulatory submissions (510(k), PMA, CE mark/MDR, etc.)
• Proven ability to interface with regulatory agencies and support audits and inspections

Skills:

• Strong understanding of global regulatory requirements and trends
• Ability to translate complex regulations into practical business strategies
• Effective cross-functional leadership and stakeholder influence
• Strong communication and organizational skills
• Ability to balance regulatory compliance with business needs in a fast-paced environment

Travel:

• Up to 10-15% international travel

This role offers high visibility, global scope, and the opportunity to shape regulatory and compliance strategy within a growing organization.