Compliance Executive

Role:

Location:

Experience

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).

• 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.

If interested kindly apply through the given link:

https://alan.keka.com/careers/jobdetails/119289