Senior Executive Regulatory Affairs

Job Summary:

Sr. Executive – Regulatory Affairs

Key Responsibilities:

• Review and approval of

  Quality Management System (QMS)

  documentation for medical devices in compliance with applicable regulations.
• Provide guidance in drafting regulatory documents for:

• Form MD-12

  (Manufacturing License)

• Form MD-17

  (Import License)

• Form MD-3

  (Loan License)
• Assist in the preparation of

  product Instructions for Use (IFU)

  and

  labeling

  in accordance with CDSCO and international regulatory guidelines.
• Review and contribute to the creation of the

  Risk Management File (RMF)

  as per

  ISO 14971

  .
• Review and finalize

  Product Dossiers

  for

  US FDA 510(k)

  or PMA submissions.
• Ensure the accuracy and completeness of all documents submitted to regulatory authorities.
• Conduct

  training sessions

  on applicable regulatory and quality standards (e.g., ISO 13485, EU MDR).
• Support and participate in

  Management Review Meetings (MRM)

  for continuous improvement and regulatory alignment.
• Stay up to date with evolving regulatory landscapes in India, the US, and other target markets.

Key Skills & Competencies:

• Strong understanding of

  CDSCO

  ,

  US FDA (21 CFR Part 820)

  ,

  EU MDR

  , and other regulatory frameworks.
• Working knowledge of

  ISO 13485

  ,

  ISO 14971

  , and other applicable standards.
• Experience in preparing technical files, product dossiers, and regulatory submissions.
• Attention to detail with excellent documentation and analytical skills.
• Effective communicator and team player with the ability to train and guide cross-functional teams.