Hiring RA & QA Associates for a Renowned Healthcare Division at BKC, Mumbai

Job Description:

Position: RA & QA Associate
Company: Renowned Healthcare Division
Location: BKC, Mumbai
Working Days: 6 Days a Week (1 Weekly Off)
Working Hours: 9:00 AM – 5:00 PM
Employment Type: Contract Basis (Payroll under Talisman HR Solution) 

Job Overview:

The Regulatory Affairs and Quality Assurance (RA & QA) Associate serves as the primary liaison for regulatory matters across the Abbott Point of Care (APOC) organization in India.
This role ensures compliance with local regulatory requirements in India and neighboring countries while maintaining alignment with global processes.

The individual provides strategic guidance to facilitate timely product approvals and market entry, and supports quality management system (QMS) compliance and oversight within the region.

Roles and Responsibilities:

1. Coordinate with regulatory authorities and internal teams to ensure compliance with applicable local and international regulations.

2. Prepare, review, and submit regulatory documentation for product registration, variations, and renewals.

3. Support internal and external audits to maintain compliance with QMS standards.

4. Monitor regulatory changes and communicate relevant updates to the organization.

5. Ensure timely renewals, licensing, and post-market surveillance activities.

6. Collaborate with cross-functional teams to ensure product and process quality compliance.

7. Maintain proper documentation and records as per company and regulatory standards.

Qualification & Experience:

• Master’s degree in Pharmacy, Biotechnology, or Life Sciences.

• 2–5 years of experience in Regulatory Affairs and Quality Assurance within the healthcare or medical device sector.

• Strong knowledge of Indian FDA, ISO standards, and global regulatory frameworks.

• Excellent communication, documentation, and coordination skills.

Additional Information:

Please note that the selected candidate will be on the payroll of Talisman HR Solution and will be working for the Renowned  Healthcare Division Abbott Healthcare Pvt Ltd  as per their work standards and requirements.
The candidate will also be eligible for statutory benefits such as PF, ESIC, and Annual Leaves.