Sr Regulatory Affairs Specialist

Overview

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.

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 has a strong sense of belonging.

What You Can Expect

Paragon 28, a Zimmer Biomet Company focused on orthopedic medical devices for the foot and ankle, is hiring a Sr Regulatory Affairs Specialist. Preferred location is Englewood, Colorado, but will consider remote candidates with the right experience. 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, identifying 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.

• 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 applicable 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 U.S. FDA 510(k) premarket submissions, 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 with cross-functional teams 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; collaborate with stakeholders to address changes.
• Support responses to regulatory body inquiries and audits by regulatory bodies.
• Review and understand global regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.).
• Assist in audits and create and maintain product labeling.
• Provide mentoring to junior level positions.

• Bachelor’s degree (Engineering, Biology, or Regulatory Science) and a minimum of 3+ years 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 and can manage cross-departmental expectations.
• Excellent written and verbal communication skills.

This position operates in a professional office environment and routinely uses standard office equipment. Travel is less than 15% of overnight travel; potential for domestic or international travel.

Salary Range: $68,000 - $96,000 USD annually depending on skills and experience. EOE.