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
Monogram Technologies is at the forefront of innovation in orthopedic robotics and personalized surgical solutions. We are developing advanced robotic systems and AI-driven tools to transform total joint arthroplasty. Join us in building cutting-edge technology to improve patient outcomes and redefine surgical precision.
This position requires an advanced understanding of medical devices and their use as well as an understanding of the regulatory submissions process, regulatory compliance of Software as a Medical Device( SaMD) and Software in a Medical Device (SiMD) products throughout their lifecycle, from development through commercialization.
How You'll Create Impact
Principal Duties and Responsibilities:
Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions
Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates
Assist 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 labeling (e.g. package inserts, product labels, GUI/splash screens)
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 and EU regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams
Follows Zimmer Biomet regulatory affairs policy and procedures
May provide training and/or guidance to entry-level associates, analysts, interns, and specialists
Communicates with regulatory and governmental agencies
Miscellaneous responsibilities as assigned
This is not an exhaustive list of duties or functions and might not necessarily comprise all 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)
Demonstrated strong writing and communication skills
Strong interpersonal skills and attention to detail
Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities
Proficient knowledge of current and emerging regulations for robotic systems, AI (Artificial Intelligence)/ML (Machine Learning) technologies, including risk management guidelines, AI-specific regulatory pathways and best practices for AI product oversight
In-depth knowledge of global regulatory frameworks (e.g. FDA, EU MDR, ISO, IEC) and standards related to AI/ML technologies, including SaMD and SiMD products
Ability to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organization
Able to identify risk in regulatory strategies
Robust product knowledge
Advanced anatomic knowledge
Proven analytical and negotiation skills
Experience with solving problems and concerns
Intermediate computer skills, including Microsoft Office Suite
Ability to lead a team and influence others
Your Background
Education/Experience Requirements
US Bachelor's Degree (or non-US equivalent) required. Technical/engineering degree, life sciences or related field preferred. Alternate degrees may be considered.
Advanced degree preferred
A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
A minimum of 3 years of experience in medical device industry with a focus on AI/ML technologies, robotic systems preferred
Regulatory Affairs Certification (US or EU) preferred
A combination of education, experience, leadership, strategy and RA influence may be considered
Physical Requirements
Travel Expectations
Up to 25%
EOE/M/F/Vet/Disability
