Regulatory Affairs & Quality Assurance Manager

Job Title:

Regulatory Affairs & Quality Assurance Executive
Location: Devine Meditech – e.g., New Delhi / Okhla /
Industry: Medical Devices (e.g., Ophthalmic Products, IOLs)
Salary: ₹40,000 to ₹60,000 per month (based on experience)
Experience Required: 3 to 5 years in RA/QA in a medical device manufacturing company

Key Responsibilities: Regulatory Affairs

• Preparation and submission of regulatory dossiers for Indian (CDSCO) and international (e.g., CE, ISO 13485) approvals
• Handle device registration, license renewals, and technical file creation
• Ensure compliance with Indian Medical Device Rules (IMDR) and applicable global regulations
• Liaise with regulatory authorities and consultants for product approvals and clarifications
• Maintain and update Device Master Files (DMF) and regulatory databases

Quality Assurance

• Implement, monitor, and maintain ISO 13485:2016 QMS
• Conduct and document internal audits, CAPA, and risk assessments
• Draft, review, and control SOPs, BMRs, validation protocols (IQ/OQ/PQ)
• Manage change control, non-conformance (NC), and customer complaint handling
• Coordinate training programs for employees on QMS and regulatory practices

Candidate Profile:

• Educational Qualification: B.Pharm / M.Pharm / B.Sc / M.Sc / B.Tech in Biotechnology, Biomedical, or related science
• Experience: 3 to 5 years in QA/RA for medical devices (especially Class B or C preferred)
• Sound knowledge of:
• ISO 13485:2016
• Indian Medical Device Rules (IMDR) 2017
• Technical File and Design Dossier compilation
• Regulatory inspections and audits
• Familiarity with ophthalmic products / surgical implants / IOLs is a plus

Key Skills:

• Regulatory documentation
• Quality Management Systems
• Problem-solving and critical thinking
• Technical writing and communication
• Internal and external audit readiness

Job Types: Full-time, Permanent

Pay: ₹30,000.00 - ₹57,873.20 per month

Benefits:

• Paid sick time

Work Location: In person