Compliance Executive

Job Description

Role: Compliance and Audit Executive (Medical Devices)

Location: Ambarnath

Band: 5B

Roles & Responsibilities:

• Collaborate with cross-functional teams to ensure compliance with MDR (India) 2017, EU MDR 2017/745, US FDA (21 CFR Part 820), MDSAP requirements, ISO 13485:2016, ISO 9001:2015, and other applicable regulatory requirements as implemented.
• Review, update, and improve existing SOPs, Work Instructions, Policies, and QMS documentation across departments to maintain regulatory compliance.
• Prepare, review, and compile Technical Documentation / Device Master Files (DMF) in accordance with applicable regulatory standards.
• Perform and support Risk Management activities as per ISO 14971, including risk analysis, evaluation, control, and reporting.
• Demonstrate sound knowledge of Process Validation, Design Controls, and Software Verification & Validation (V&V) activities.
• Support regulatory compliance related to the import, manufacture, distribution, and sale of medical devices in India.
• Conduct internal audits and provide support during external audits (Notified Bodies, Regulatory Authorities, Customers).
• Handle Post-Market Surveillance (PMS) activities, including complaint handling, vigilance reporting, and trend analysis.
• Apply Root Cause Analysis (RCA) techniques and manage Corrective and Preventive Actions (CAPA) effectively.

Education and Experience

• Bachelor’s degree in Science or Engineering (Biomedical, Electronics, Mechanical, or related disciplines).
• 0–2+ years of experience in regulatory compliance, quality assurance, or the medical device industry.
• ISO 13485 Internal Auditor / Lead Auditor certification is an added advantage.
• Exposure or hands-on experience with US FDA regulations and MDSAP audits will be an added advantage.
• Strong analytical skills with the ability to interpret and apply complex regulatory and quality requirements.
• High learning agility with demonstrated aptitude for understanding and implementing regulatory standards.

Job Type: Full-time

Pay: ₹20,000.00 - ₹50,000.00 per month

Benefits:

• Food provided
• Health insurance
• Provident Fund

Work Location: In person