Assoc Reg Affairs Specialist

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

Paragon 28, a Zimmer Biomet company, is hiring an Associate Regulatory Affairs Specialist. The Regulatory Associate will assist the Regulatory Affairs team in ensuring that Paragon 28 products meet all global regulatory requirements, while gaining valuable experience in the regulatory landscape. This role will provide the opportunity to collaborate with cross-functional teams to support regulatory submissions and maintain a variety of regulatory systems to ensure on-going compliance.

How You'll Create Impact

Essential Responsibilities and Duties

• Coordinate the product labeling process and assist with label content management and verification

• Assist with maintenance of regulatory files, resources and databases (both internal and external)

• Support Regulatory Specialists with the preparation of regulatory documents for submission to health authorities

• Other tasks as directed by management

Your Background

Required Qualifications

• Bachelor’s degree in life sciences, engineering, or a related field

• Desire to establish a career in Regulatory Affairs

• Strong attention to detail and excellent organizational skills

• Ability to prioritize tasks and manage time effectively

• Ability to work collaboratively in a team environment

• Effective communication skills, both written and verbal

• Fluent in Word, Excel, PowerPoint, Outlook

Preferred Qualifications

• Internship or coursework related to regulatory affairs or compliance

• Familiarity with FDA or other regulatory agency guidelines

• Knowledge of Good Manufacturing Practices (GMP) and quality systems

• MS Access database, Sharepoint and Smartsheet experience desired

Compensation Data

$58,000 - $73,000 USD annually depending on skills and experience

EOE