Sr. Reg. Affairs Specialist

Location

Westminster, CO | United States

Job description

Welcome to ZimVie, a publicly traded global company focused on restoring daily life to our patients. Our company is founded on a legacy of established brands, medical experts and over $900M in annual revenue. We design, manufacture, and distribute a comprehensive portfolio of innovative solutions for implant dentistry, spinal surgery, and bone growth stimulation. Our seasoned leadership and dedicated global team of more than 2,700 is focused on shaping an exciting future for ZimVie — we hope you’ll consider being a part of it!

Job Summary:

This position requires an advanced understanding of medical devices and their use as well as an understanding of the regulatory submissions process.

Principal Duties and Responsibilities:

• 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, evaluations, and approves promotion and advertising material for compliance with applicable regulations
• Communicates with regulatory and governmental agencies
• 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
• 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
• Reviews proposed labeling for compliance with applicable US and international regulations
• Collaborates on the development of package inserts; reviews package inserts for release
• Follows ZimVie regulatory affairs policy and procedures
• May provide training and/or guidance to entry-level associates, analysts, interns, and specialists
• Miscellaneous responsibilities as assigned

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

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 overall business environment, the orthopedic industry, and the marketplace
• Mastery of relevant regulations pertinent to medical devices and biologics as applicable 
• 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
• 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
• Proficient knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU
• Ability to manage communications with global regulatory agencies

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 required
• A minimum of 2 years of experience in orthopaedic or medical device industry preferred
• Regulatory Affairs Certification (US or EU) preferred
• Direct experience managing Class II and Class III (US/EU) devices
• Experience acting as primary contact for global regulatory filings (focus on US & EU)
• A combination of education, experience, leadership, strategy, and RA influence may be considered

Travel Requirements

Up to 15%

ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, demotion, evaluation, compensation, and separation, are considered without regard to race, color, religion, religious beliefs, creed, national origin, ancestry, citizenship status, age, gender/sex (including pregnancy, childbirth, related medical conditions, lactation and breastfeeding), gender identity or expression (including transgender status), sexual orientation, marital status, military status, protected veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any other status protected under applicable federal, state and local laws.

ZimVie generally does not sponsor applicant work visas for this position.

Requisition ID: 2464 

Job tags

Salary