Company Description ZimVie is a global life sciences company focused on dental implants, biomaterials, and digital dentistry solutions that support tooth replacement and restoration procedures. The organization offers a comprehensive portfolio, including dental implant systems, digital solutions, advanced workflows, and biomaterials designed to simplify procedures and enhance clinical outcomes. Headquartered in Palm Beach Gardens, Florida, with operations worldwide, ZimVie is dedicated to improving smiles, function, and confidence in daily life.

As a recognized leader in its field, the company is committed to advancing clinical science and technology that underpin effective and reliable tooth replacement solutions.

Regulatory Affairs & Quality Assurance Specialist - APAC

We are looking for a detail-oriented and proactive Regulatory Affairs & Quality Assurance Specialist to support medical device product registrations across India and other APAC markets. This role will be responsible for managing regulatory submissions, maintaining regulatory databases and quality management documentation, and supporting compliance with applicable medical device regulations and standards.

The ideal candidate will have experience in medical device regulatory affairs and quality systems, strong attention to detail, and the ability to work effectively with cross-functional and international teams.

Key Responsibilities

- Manage medical device product registrations in India, including initial registrations, post-approval activities, amendments, and renewals.
- Support and manage product registration activities across other APAC markets.
- Maintain and update internal regulatory databases and ensure regulatory information is accurate and current.
- Prepare, review, approve, distribute, and support training related to Quality Management System (QMS) documentation.
- Participate in and support internal and external audits.
- Provide training and guidance to relevant departments on quality and regulatory procedures,



as required.
- Monitor and assess new or updated regulations, standards, and applicable national laws impacting medical device products.
- Communicate relevant regulatory updates and changes to internal stakeholders.
- Respond to market and customer-related regulatory requests and support Customer Service teams in providing required product and regulatory information.
- Collaborate closely with Regulatory Affairs, Quality, Commercial, and other cross-functional teams across the APAC region.
- Support additional Regulatory Affairs and Quality Assurance activities as required.

What We're Looking For

Education & Experience

- Bachelor’s or Master’s degree in Biological Sciences, Life Sciences, or a related discipline.
- 3–5 years of experience in Regulatory Affairs and/or Quality Assurance within the medical device industry.
- Strong understanding of medical device regulatory requirements and quality systems.
- Experience with medical device product registrations and regulatory submissions is preferred.
- Familiarity with applicable regulations, standards, and Quality Management Systems.

Skills & Competencies

- Strong written and verbal communication skills in English.
- Excellent attention to detail and organizational skills.
- Ability to manage multiple priorities and meet deadlines effectively.
- Strong teamwork and collaboration skills.
- Proactive, flexible, and solution-oriented approach.
- Ability to work effectively in a fast-paced environment and manage pressure.
- Good computer skills and proficiency in commonly used software and databases.

Key Stakeholders

Internal:

- Regulatory Affairs teams
- Quality teams
- APAC Commercial teams
- Cross-functional business teams

External:

- APAC Competent Authorities
- Auditors
- Consultants
- Suppliers
- Distributors

Travel Requirement

- Approximately 10% travel may be required.

If you have a passion for ensuring medical devices meet regulatory and quality requirements and enjoy working in a collaborative, international workplace, we would love to hear from you.

📌 QA&RA Specialist - APAC (Contractual Role - 6 months) (Mumbai)
🏢 ZimVie
📍 Mumbai