Job Summary

 

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 AI/ML products throughout their lifecycle, from development through commercialization.   

 

 

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 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 of the essential functions for purposes of the Americans with Disabilities Act.

 

 

Expected Areas of Competence (i.e., knowledge, skills and abilities)

 

Demonstrated strong writing and communication skillsStrong interpersonal skills and attention to detailAbility to manage several competing priorities; versatility, flexibility, and willingness to work with changing prioritiesProficient knowledge of with current and emerging regulations for AI/ML technologies, including risk management guidelines, AI-specific regulatory pathways and best practices for AI product oversightIn-depth knowledge of global regulatory frameworks (e.g. FDA, MDR, ISO, IEC) and standards related to AI/ML technologies, including software as a medical device (SaMD) and digital health products Ability to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organizationAble to identify risk in regulatory strategiesRobust product knowledgeAdvanced anatomic knowledgeProven analytical and negotiation skillsExperience with solving problems and concernsIntermediate computer skills, including Microsoft Office SuiteAbility to lead a team and influence others 

 

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 preferredA minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field requiredA minimum of 3 years of experience in medical device industry with a focus on AI/ML technologies, digital health products preferredRegulatory Affairs Certification (US or EU) preferredA combination of education, experience, leadership, strategy and RA influence may be considered

 

Travel Requirements

 

Up to 15%

 

Salary: 90-133k USD 

What You Can Expect How You'll Create Impact What Makes You Stand Out Your Background Travel Expectations

EOE/M/F/Vet/Disability