Zimmer Biomet · 18 hours ago
Regulatory Affairs Sr Specialist
United States
Full-time
Remote
Senior Level
5+ years expZimmer Biomet is a global medical technology leader focused on enhancing patient mobility through innovative products. The Regulatory Affairs Sr Specialist will oversee the regulatory submissions process, ensure compliance for medical devices, and provide strategic regulatory direction for new products.
Health CareManufacturingMedical DeviceProduct Design
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
Qualification
Required
US Bachelor's Degree (or non-US equivalent) required
A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
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
Preferred
Technical/engineering degree, life sciences or related field
Advanced degree
A minimum of 3 years of experience in medical device industry with a focus on AI/ML technologies, robotic systems
Regulatory Affairs Certification (US or EU)
Benefits
Development opportunities
Robust employee resource groups (ERGs)
A flexible working environment
Location specific competitive total rewards
Wellness incentives
A culture of recognition and performance awards
Company
Zimmer Biomet
Zimmer Biomet is a medical device manufacturing company that offers orthopedic reconstructive, spinal, and trauma devices.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$2.75B2025-02-20Post Ipo Debt· $1.75B
2016-12-14Post Ipo Debt· $1B
2001-08-03IPO
Leadership Team
Ivan Tornos
Chairman, President and CEO
D
David DeMartino
Senior Vice President, Investor Relations
Recent News
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