Sr Manager, Regulatory Affairs

Paragon 28, Inc.•Englewood, CO

7d•$120,000 - $150,000•Hybrid

About The Position

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging. 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.

Requirements

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

Responsibilities

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