QA Executive (Eumdr)

We are looking for a skilled and detail-oriented QA Executive to join our team. The candidate will be responsible for ensuring the quality and regulatory compliance of medical devices in line with EU MDR 2017/745 and Indian Medical Device Rules (IMDR). This role involves preparing, reviewing, and updating key technical and regulatory documentation and supporting post-market surveillance activities.

Roles & Responsibilities

• Preparation, review, and updating of

  Technical Files

  as per

  EU MDR 2017/745

  and

  Device Master Files (DMF)

  as per

  IMDR

  .
• Maintenance of

  General Safety and Performance Requirements (GSPR)

  documentation in compliance with applicable guidelines.
• Preparation of

  Risk Management Plans and Reports

  as per ISO 14971 and other applicable standards.
• Development and review of

  Clinical Evaluation Protocols and Reports (CEP/CER)

  as per MDR/IMDR guidelines.
• Preparation and maintenance of

  Post-Market Surveillance (PMS)

  ,

  Post-Market Clinical Follow-up (PMCF)

  , and

  Periodic Safety Update Reports (PSUR)

  .
• Documentation of

  Design and Development

  activities, ensuring alignment with regulatory and internal design control requirements.
• Drafting and reviewing

  Usability Engineering Protocols and Reports

  in compliance with ISO 62366.
• Monitoring, tracking, trending, and reporting of all

  reportable events

  , including

  serious/adverse incidents

  and

  field safety corrective actions (FSCA)

  .
• Keeping up to date with current

  national and international regulations, standards, and best practices

  relevant to the medical device industry.
• Ensure proper handover of responsibilities to designated personnel during absence.
  

Desired Candidate Profile

• Prior experience in

  quality assurance or regulatory affairs

  for medical devices.
• In-depth understanding of

  EU MDR 2017/745

  ,

  IMDR

  , and related standards (e.g., ISO 13485, ISO 14971, ISO 62366).
• Strong documentation and review skills.
  
• Attention to detail with good organizational and analytical abilities.
  
• Effective communication skills and the ability to work independently as well as in a cross-functional team.