Sr Manager, Regulatory Affairs

About the role

Paragon 28, a premier Zimmer Biomet company, is seeking an ambitious Senior Manager of Regulatory Affairs, Domestic, to spearhead our United States regulatory footprint. In this high-impact leadership role, you will collaborate with cross-functional innovators to build and execute winning US regulatory strategies from concept to commercialization. Backed by the global scale of Zimmer Biomet, you will champion both high-stakes new product introductions and critical market maintenance, ensuring our life-changing medical devices reach patients without delay. As a key leader, you will directly manage, mentor, and inspire a dedicated team of regulatory professionals. If you are ready to own the US market strategy and drive a fast-paced team to success, apply today. This position will require onsite presence at least 3 days a week at our Englewood, Colorado location.

How You'll Create Impact

• Review, assess and improve the suitability of the quality system for regulatory processes such as: US FDA Premarket Approval, US FDA HUD/HDE for Humanitarian Use/Humanitarian Device Exemption, US FDA Section 520(b) Custom Device Exemption, US FDA Compassionate Use, US FDA Investigational Device Exemption, US Premarket Notification (510(k)), and Human Cell and Tissue Products (HCT/P) as needed
• Oversee submission of regulatory applications for the applicable pathways shown above
• Establish and maintain regulatory schedules to achieve company timeline and budget goals
• Ensure that internal and external systems and documentation is maintained according to established processes and in a timely manner (e.g., RIMS, GUDID, etc.)
• Review regulatory strategy proposals
• Collaborate with departmental leadership to navigate and establish regulatory prioritization based on direction from executive management
• Understand regulatory concepts and present/train cross-functional departmental staff on compliance (clinical, quality, engineering, etc.)
• Understanding and execution of complex labeling strategies
• Ensure regulatory registrations and listings occur on schedule
• Oversee regulatory reporting on behalf of the company
• Build and mentor the Domestic regulatory team to achieve company goals
• Provide support and guidance to development and maintenance of processes required for global distribution of custom devices
• Other tasks as directed by management

Requirements

• Bachelor's degree and at least 7 years of relevant experience
• Technical, engineering, or scientific degree preferred
• RAC credential a plus
• Strong technical acumen surrounding complex regulatory strategies
• Expertise in applicable regulations including: ISO 13485:2016 and US 21 CFR
• Must have a strong familiarity with US FDA requirements and processes
• Demonstrated leadership style that motivates team performance by communicating a company vision and providing coaching to a team of regulatory professionals
• Ability to handle multiple priorities and meet key deadlines under pressure through effective time management skills
• Proven ability to lead, establish, maintain and influence effective working relationships with internal stakeholders across functional groups
• Fluent in Word, Excel, PowerPoint, Outlook

Pay

Salary Range: $120,000-$150,000

Travel Expectations

Up to 10% overnight travel required