We are ZimVie, a 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
- To complete product registration on assigned projects for India and other APAC countries
- To maintain relevant RA work for database.
- To maintain quality management system
- To assist and support other related duties for RA&QA Dept.
Principal Duties and Responsibilities
- Responsible for medical device products registration in India, include initial, post-approval and renewal registration.
- Responsible for product registration in APAC region.
- Maintain and update international internal regulatory databases.
- Prepare, review, approve, distribution and training on Quality Management documentation.
- Participate on external and internal audits.
- Training to other departments on quality & regulatory procedures as needed.
- Participate in the assessments of the new or updated regulations and standards applicable to the products, and national laws for any new or updated revisions. Communicate updates to regulatory staff.
- Respond to all market requests (customers, distributors and others) and support CS in providing information to customers.
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions".
Expected Areas of Competence (i.e. KSAs)
- Good communication skill.
- Good teamwork and actively attitude.
- Effectively managing one’s time and resources to ensure that work is completed efficiently.
- Actively participating as a member of a team to move the team toward the completion of goals.
- Attention to detail, initiative, and flexibility, used to work with deadlines, stress Resistant
Education/ Experience Requirements
- Bachelor’s or master’s degree or above in biological or related sciences.
- Above 3-5 years working experience on regulatory and quality in the field for medical device.
- Professional knowledge on medical device regulatory affairs & quality field.
- Computer skills and be proficient with commonly used software.
- Good at written and oral in English.
Main Relationship
- Internal
-
- Regulatory Affairs (BCN & PBG)
- Quality (BCN, PBG, & VLC)
- APAC Commercial team.
- External
-
- APAC Competent Authorities
- Auditors
- Consultants
- Suppliers
- APAC
-
- Distributors
Travel Requirements
10%
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: 3390
