Regulatory 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:
Responsible for assisting the team with regulatory filings as necessary to market ZimVie products. This position requires an intermediate understanding of 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 package inserts
- Reviews and evaluations 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)
- Strong writing, communication, and interpersonal skills
- Strong attention to detail; ability to multi-task and balance competing priorities
- Knowledge of overall business environment, the orthopaedic industry, and the marketplace
- Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area \
- Ability to building 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
- Strong problem solving skills
- Effective negotiating skills
- Basic computer skills, including Microsoft Office Suite
Education/Experience Requirements
- Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
- A minimum of one year of experience in orthopaedic or medical device industry preferred
- A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, 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%
Salary Range: $61,800.00 to 81,200.00
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: 2521
Job tags
Salary
