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

Fuel the Future of Foot and Ankle Innovation!

Paragon 28 (a Zimmer Biomet company) is on a mission to redefine orthopedic care for the foot and ankle. We are looking for a high-energy Regulatory Affairs Specialist II to help launch our cutting-edge medical devices into global markets. This position will be based out of our location in Englewood, Colorado.

If you are a proactive problem-solver who thrives on collaboration, navigating global compliance, and turning complex regulations into successful product launches, we want you on our team!

Your Impact

• Drive Global Strategy : Craft and execute winning regulatory strategies for the US, Canada, and expanding international territories.

• Lead Submissions : Own the lifecycle of critical submissions and maintain direct, professional communication with major government agencies like the FDA and Health Canada.

• Cross-Functional Collaboration : Partner daily with brilliant minds in Engineering, Quality, and Regulatory Affairs to bring life-changing devices from concept to market.

• Champion Quality : Act as a gatekeeper for safety and compliance by performing vital regulatory assessments and quality system reviews.

What You Bring

• Masterful navigation of FDA and Health Canada regulations.

• Experience writing and managing successful medical device submissions.

• Strong collaboration skills to bridge the gap between engineering innovation and regulatory compliance.

• A sharp eye for detail when auditing quality management system documents.

Ready to accelerate your career with an industry leader? Apply today and step into a role where your work directly improves patient mobility worldwide!

How You'll Create Impact

• Review and understand global regulatory requirements (FDA, TGA, EU MDD, EU MDR, Health Canada, etc.)

• Maintain compliance to FDA UDI requirements

• Assemble and maintain regulatory files (510(k) submissions, STED, Technical Files, etc.)

• Assist engineering in implementing verification and validation strategies

• Work with regulators to release products into new or established markets

• Review and establish predicates for FDA premarket notifications

• Review competitive literature to develop regulatory strategies

• Support project teams in decisions that affect regulatory compliance

• Review marketing literature for regulatory compliance

• Registration and listing of devices

• Create and maintain product labeling

• Knowledge of GMPs

• Other duties as assigned

Your Background

• Bachelor's degree in a technical field (Engineering, Biology, or Regulatory Science) and 3-7 years of regulatory experience; or equivalent combination of education and experience.

• Knowledge of 21 CFR Part 820, EU MDD 93/42/EEC, EU MDR 2017/745, and ISO 13485

• Understanding of orthopedic and/or implantable devices; previous medical device industry experience required

• 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

• Proficiency with FDA's eSTAR submission tool

• 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

10% of overnight travel.

Compensation Data

Salary Range: $60,000 - $90,000 USD Annually

EOE