What You Can Expect
Elevate your career and lead the future of foot and ankle orthopedics with an industry powerhouse. 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
Your Background
- Requires a 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
Travel Expectations
Up to 10% overnight travel required
Compensation Data
Salary Range: $120,000-$150,000
