Regulatory Affairs Specialist (On-site)

We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life by advancing clinical technology to improve patients’ smiles, function, and confidence. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves – their best selves – to work every day to accomplish our Mission. Together, our dedicated, diverse global team is shaping an exciting future for ZimVie — we hope you’ll consider being a part of it!

Job Summary:

Responsible for assisting the team with regulatory filings as necessary to market ZimVie products. The Regulatory Affairs Specialist incumbent requires to have a general understanding of ZimVie medical devices and their use, as well as an understanding of the regulatory submission process.

Principal Duties and Responsibilities

• Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions.
• Respond to requests from foreign government and/or distributors as needed
• Assist with the 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
• Evaluate risk of proposed regulatory strategies; may offer solutions
• Reviews proposed labeling for compliance with applicable global regulations
• Writes and manages the development of instructions for use 
• Reviews and evaluates promotion and advertising material for compliance with applicable regulations
• Reviews proposed product changes for impact on regulatory status of the product
• Communicates with regulatory and governmental agencies with supervision
• Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams.

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)

• Ability to draft and review regulatory documents, such as 510(k)s, Letters-to-File and EU MDR Technical Documentation
• Proficient writing, communication, and interpersonal skills
• Attention to detail is critical for this role; ability to multi-task and balance competing priorities is required
• Knowledge of overall business environment, the medical device industry, and the marketplace
• Ability to learn and stay abreast of regulations pertinent to medical devices. Knowledge in the dental field is a plus.
• Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
• Knowledge of FDA, EU, and other regulatory body regulations
• Ability to identify risk in Regulatory strategies and propose actions to prevent regulatory setbacks
• Critical thinking to address regulatory challenges and ensure compliance
• Effective negotiating skills focused on compliance and regulatory submissions.
• Basic computer skills, including Microsoft Office Suite

Education/Experience Requirements

• Typically, requires a bachelor’s degree in Life Science, Biomedical Engineering, Pharmacy, Chemistry or a related field.
• A minimum of one year of experience in the medical device industry preferred
• A minimum of 2 - 3 years of experience in Regulatory Affairs, Quality Assurance, or related field required
• Regulatory Affairs Certification (US or EU) preferred
• A combination of education and experience 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: 3157