Job Description

Welcome to ZimVie, a new, publicly traded global company focused on improving quality of life for our patients. Our company is founded on a legacy of established brands, medical experts and over $1B 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 2,500 is focused on shaping an exciting future for ZimVie \xe2\x80\x94 we hope you\xe2\x80\x99ll consider being a part of it!
Job Summary: This position will be responsible for assisting with all regulatory filings as necessary to market ZimVie products which includes developing regulatory submissions, managing projects, reviewing labelling and HCP materials, providing guidance and consultation for regulations. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.
Job 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.
• Work closely with global and regional RA team to drive reduction of registration cycle time through Speed to Market initiatives.
  • Define and implement countries regulatory strategy, plan and budget.
  • Manage and track Speed to Market performance for India and other Export Markets.
  • Update significant and comprehensive commentary report on a monthly, quarterly and yearly basis.
• Manage product approval process and responsible for clearing approval and other barriers to ensure timely market release of new products with appropriate licenses
• Oversee and ensure development, implementation and compliance of relevant SOPs and execute regulatory operations such as Global Distribution Regulatory Controls and Regulatory Information Management System.
• Oversee copy review process implementation which includes advertising and promotional materials and relevant internet activities and publications to comply with all relevant internal policies and local country regulations.
• Coordinate with global and regional RA team on Quality field actions & post-market requirements.
• Manage the implementation of GDPMD in the country.
• Manage the External Audits such as CAB (Conformity Assessment Body).
• Manage the Internal Audits
• Manage the SOP, WI and the overall QMS (Quality Management System) of the organization.
• Keeps all stakeholders of ZimVie informed of regulatory requirements and emerging issues which may affect the registration approval of products in the countries of responsibility
• 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 product changes for impact on regulatory status of the product.
• Communicates with Regulatory and governmental agencies with supervision.
• Respond to requests from foreign government and/or distributors as needed

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions".
Job Requirements:

• Bachelor\xe2\x80\x99s Degree in life sciences, technical (engineering) or related field; advanced degree strongly preferred.
• Minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required .
• A minimum of one year experience in the areas of medical devices, drugs, biologics, and combination products regulations is strongly preferred.
• A combination of education and experience may be considered. Business proficiency in spoken and written English
• Strong writing, communication, and interpersonal skills
• Strong attention to detail; ability to multi-task and balance competing priorities
• Strong computer skills (MS Excel)
• Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels.
• Ability to identify risk in Regulatory strategies
• Strong problem solving skills
• Effective negotiating skills

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, national origin, ancestry, sex, sexual orientation, gender, gender identity, gender expression, transgender status, religion, religious beliefs, age, marital status, physical or mental disability, pregnancy status (including childbirth, lactation, breastfeeding or related medical conditions), parental status, genetic characteristics or information (including family medical history), political affiliation, military or veteran status or other classifications protected by applicable federal, state and local laws.
Requisition ID: [[1825]]