Regulatory Affairs Associate
Zimmer Biomet · Warsaw, Indiana ·
- Seniority
- Junior
- Category
- Legal
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 talent 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 included, respected, empowered and recognised.
What You Can Expect
Responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. This is an entry level position, providing training towards full competency in Regulatory Affairs (RA). This position requires a basic understanding of medical devices and their use as well as a basic understanding of the regulatory submissions process. May perform some or all of the following functions, depending on specific assigned focus.
How You'll Create Impact
Principal Duties and Responsibilities:
• Coordinate and assist in the preparation of technical documentation for use in regulatory submissions worldwide
• Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
• May aid in regulatory direction to development project teams as a core team member; supports regulatory strategy for new products
• Reviews proposed labeling for compliance with applicable international and country regulations
• Support development of package inserts
• Reviews and evaluates promotion and advertising material for compliance with applicable regulations
• Supports and reviews proposed product changes for impact on regulatory status of the product
• Follows Zimmer Biomet RA policies and procedures
• Miscellaneous responsibilities as assigned
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
What Makes You Stand Out
Expected Areas of Competence (i.e., knowledge, skills and abilities)
• Strong writing, communication, and interpersonal skills
• Strong attention to detail
• Strong problem-solving and analytical skills
• Ability to work with rapid changes; flexible and able to balance competing priorities
• Ability to learn and apply regulations pertinent to medical devices, biologics, drugs and combination products, specific to functional work team
• Self-motivated and capable to work in a diverse, fast-paced and dynamic environment
• Ability to build strong relationships; communicate effectively at all levels
• Basic computer skills, including Microsoft Office Suite
Your Background
Education/Experience Requirements
• Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field preferred
• Limited regulatory submission preparation experience a plus
EOE/M/F/Vet/Disability