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