Regulatory Affairs Senior 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 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
As a Regulatory Affairs Senior Specialist, you be join our CMF&T team (craniomaxillofacial & thoracic solutions).
This position requires an advanced understanding of medical devices and their use as well as an understanding of the regulatory submissions process.
How You'll Create Impact
- Assists with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions.
- Responds to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provides routine regulatory information to associates and affiliates.
- Assists with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
- Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
- Evaluates risk of proposed regulatory strategies and offers solutions.
- Reviews proposed labeling for compliance with applicable US and international regulations.
- Writes, manages, and approves the development of package inserts.
- Reviews, evaluations, and approves promotion and advertising material for compliance with applicable regulations.
- Reviews proposed product changes for impact on regulatory status of the product
- Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams.
- Communicates with regulatory and governmental agencies.
What Makes You Stand Out
- Demonstrated strong writing and communication skills
- Proven analytical and negotiation skills, attention to detail
- Experience with solving problems and concerns
- Ability to identify risk in regulatory strategies
- Proficient knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU
- Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities
Your Background
You hold a US Bachelor’s Degree (or non-US equivalent), ideally in technical/engineering, life sciences or related field, combined with min 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field.
Experience in CMF&T, orthopaedic or medical device industry is a strong asset.
Regulatory Affairs Certification (US or EU) is preferred.
Travel Expectations
Up to 15%.
EOE/M/F/Vet/Disability
