Sr Manager, Regulatory Affairs

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.What You Can ExpectElevate 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 ImpactReview, assess and improve the suitability of the quality system for regulatory processes such as:US FDA Premarket ApprovalUS FDA HUD/HDE for Humanitarian Use/Humanitarian Device ExemptionUS FDA Section 520(b) Custom Device ExemptionUS FDA Compassionate UseUS FDA Investigational Device ExemptionUS Premarket Notification (510(k)), and Human Cell and Tissue Products (HCT/P) as neededOversee submission of regulatory applications for the applicable pathways shown aboveEstablish and maintain regulatory schedules to achieve company timeline and budget goalsEnsure 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 proposalsCollaborate 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 strategiesEnsure regulatory registrations and listings occur on scheduleOversee regulatory reporting on behalf of the companyBuild and mentor the Domestic regulatory team to achieve company goalsProvide support and guidance to development and maintenance of processes required for global distribution of custom devicesOther tasks as directed by managementYour BackgroundRequires a bachelor’s degree and at least 7 years of relevant experience. Technical, engineering, or scientific degree preferred.RAC credential a plusStrong technical acumen surrounding complex regulatory strategiesExpertise in applicable regulations including: ISO 13485:2016 and US 21 CFRMust have a strong familiarity with US FDA requirements and processesDemonstrated leadership style that motivates team performance by communicating a company vision and providing coaching to a team of regulatory professionalsAbility 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, OutlookTravel ExpectationsUp to 10% overnight travel requiredCompensation DataSalary Range: $120,000-$150,000EOEJob SummaryJob number: 11624Profession: Quality & RegulatoryType: Full-Time