Regulatory Affairs & Quality Assurance Executive

Job Summary

We are seeking a detail-oriented Assistant or RAQA Executive to support Regulatory Affairs and Quality Assurance activities for laboratory equipment and/or medical devices. The role involves assisting with regulatory documentation, quality system maintenance, compliance activities, and coordination with cross-functional teams to ensure products meet applicable regulatory and quality requirements.

This position is ideal for early-career professionals looking to build expertise in regulated industries.

Key Responsibilities

• Assist in preparation, compilation, and maintenance of regulatory documentation such as Technical Files, Device Master Records (DMR), and product dossiers
• Support product registrations, renewals, and variations under applicable regulations (CE, FDA, CDSCO, or local regulations) under supervision
• Assist in regulatory submission tracking, timelines, status reporting and support internal audit preparation, execution, and follow-up activities
• Support labelling, IFU, and packaging compliance reviews and monitor regulatory updates and support impact assessment on existing products
• Coordinate with R&D, Production, and QA teams to gather regulatory inputs and assist in external audit and inspection readiness (certification bodies, regulatory authorities)
• Maintain regulatory records, databases, and document repositories and assist in creation, review, and control of SOPs, work instructions, formats, and quality records
• Support implementation and maintenance of the Quality Management System (QMS) in line with ISO 9001 / ISO 13485
• Support deviation management, non-conformance reporting, CAPA, and change control documentation
• Assist in risk management documentation, product quality reviews and support supplier quality activities including documentation review and evaluations
• Assist in validation, calibration of equipment qualification documentation and maintain training records and support compliance to training requirements
• Support departmental objectives through activities delegated by the reporting manager.

Required Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Biotechnology, Pharmacy, Chemistry, or related field
• 1 to 3 years of experience or internship exposure in RA/QA or regulated industries
• Basic understanding of: ISO 9001 / ISO 13485, Regulatory requirements for laboratory equipment or medical devices & Documentation and quality systems.
• Good written and verbal communication skills with strong attention to technical detail and organizational skills.

Preferred Skills

• Exposure to CE marking, FDA, CDSCO, or other regional regulatory frameworks.
• Familiarity with audits and regulatory inspections
• Understanding of risk management standards & Experience with document management systems
• Ability to work collaboratively in a cross-functional environment

Job Type: Full-time

Pay: Up to ₹450,000.00 per year

Benefits:

• Flexible schedule
• Health insurance
• Leave encashment
• Provident Fund

Application Question(s):

• Please specify your experience with regulatory frameworks such as CE Marking, FDA, CDSCO, or other regional regulations. Mention the frameworks you have worked with and your total years of hands-on experience with each.
• How many years of experience do you have in supporting or handling regulatory audits and inspections?
• Please indicate your years of experience with risk management standards (e.g., ISO 14971) and document management systems, along with the type of systems or tools used.

Education:

• Bachelor's (Preferred)

Language:

• English (Preferred)

Work Location: In person