Regulatory Affairs Specialist II

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 Expect

The Sr. Regulatory Affairs Specialist serves as the lead regulatory representative on Paragon 28 product and project teams supporting product lifecycle management activities. Responsibilities include developing regulatory strategies, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses and interacting with regulatory agencies.

How You'll Create Impact

• Serve as the global regulatory liaison and primary point of contact for product and project teams for Paragon 28 software applications and surgical system hardware
• Maintain expert knowledge of appropriate regulations, legislation, best practices, and guidelines related to Artificial Intelligence, Software as a Medical Device and Machine Learning (SaMD/ML)
• Provide regulatory guidance to product teams, develop regulatory strategies, and review and approve product design control documentation
• Determine regulatory pathways and formulate regulatory strategies for the U.S. market.
• Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes
• Influence and lead global regulatory strategies
• Author and lead regulatory documentation and submissions, including (but not limited to) U.S. FDA 510(k) premarket notifications, De Novo applications, internal Letters to File, and pre-submissions, with minimal supervision
• Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals
• Provide risk-based guidance and regulatory input to projects and issues, ensuring cross-functional alignment and resolution
• Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts
• Perform timely reviews of collateral Marketing material for responsible product lines.
• Build relationships and interface with cross-functional teams (Engineering, Manufacturing, Marketing, etc.) to ensure accurate, complete, and timely submission preparation
• Build and conduct regular training in the area of software development, software as a medical device and cybersecurity
• Assess impact of changes to applicable laws and regulations and identify impact to the business and in collaboration with other stakeholders, develop strategies to address such changes
• Support responses to regulatory body inquiries and support audits by regulatory bodies
• Review and understand global regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.)
• Assist in audits
• Create and maintain product labeling
• Provide mentoring to junior level positions
  
  

What Makes You Stand Out

• Proven experience with software as a medical device (SaMD) and mobile health app regulations
• In-depth knowledge of FDA guidance on digital health, cybersecurity, and mobile medical apps
• Track record of 510(k)/De Novo submissions for connected orthopedic or wearable devices
• Familiarity with IEC 62304, ISO 13485, and FDA Part 11 compliance for software validation
• Experience with EU MDR requirements for software and app-based devices (Annex I & XIII)
• Regulatory strategy development for Bluetooth/Wi-Fi enabled orthopedic technologies
• Effective collaboration with software, clinical, and human factors teams
• Post-market compliance expertise, including UDI, vigilance, and software change reporting
• Strong understanding of cybersecurity requirements and guidance (e.g., FDA, IMDRF)
• RAC certification or equivalent, with ongoing education in digital health regulations
  
  

Your Background

• Bachelor’s degree (Engineering, Biology, or Regulatory Science) and a minimum of 3 year(s) related experience; or equivalent combination of education and experience.
• Knowledge of US and/or international regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.)
• Direct experience with regulatory submissions for Artificial Intelligence, Software as a Medical Device and Machine Learning (SaMD/ML) products
• Understanding of orthopedic devices
• History of working collaboratively across functions
• Excellent attention to detail and proven organizational skills, able to prioritize and multi-task and see projects/assignments to completion
• Proficiency in Excel, Word, PowerPoint, Outlook and customer database management systems
• Proven leadership and negotiation skills, works well with all levels, able to successfully manage cross-departmental expectations
• Excellent written and verbal communication skills
  
  

Travel Expectations

Less than 15% of overnight travel; potential for either domestic or international travel.

Compensation Data

Expected Salary Range: $88,500 - $110,000 USD annually, depending on experience

EOE