Regulatory Affairs Specialist II

About the role

Paragon 28 (a Zimmer Biomet company) is seeking a high-energy Regulatory Affairs Specialist II to support the launch of cutting-edge medical devices globally. The position is based in Englewood, Colorado.

Responsibilities

• 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.
• Collaborate Cross-Functionally: 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.

Requirements

• 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.

Qualifications

• 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.
• Proven leadership and negotiation skills, works well with all levels, able to successfully manage cross-departmental expectations.
• Excellent written and verbal communication skills.

Skills

• Knowledge of global regulatory requirements (FDA, TGA, EU MDD, EU MDR, Health Canada, etc.).
• Ability to review and understand global regulatory requirements.
• Experience in assembling and maintaining regulatory files (510(k) submissions, STED, Technical Files, etc.).
• Ability to assist engineering in implementing verification and validation strategies.
• Experience working with regulators to release products into new or established markets.
• Ability to review and establish predicates for FDA premarket notifications.
• Experience in developing and reviewing regulatory strategies based on competitive literature.
• Ability to review marketing literature for regulatory compliance.
• Experience in registration and listing of devices.
• Experience in creating and maintaining product labeling.
• Knowledge of Good Manufacturing Practices (GMPs).

Benefits

• Location-specific competitive total rewards package.
• Wellness incentives.
• Culture of recognition and performance awards.

Pay

$60,000 - $90,000 USD Annually

Schedule

Flexible working environment.