Sr. Executive RA

We are seeking a highly motivated and detail-oriented Sr. Executive Regulatory Affairs with experience in medical devices to join our Regulatory team. The ideal candidate will have hands-on experience with Indian and international regulatory requirements, including CDSCO, USFDA, and applicable ISO standards. The role involves preparing and reviewing QMS and product documentation, supporting regulatory submissions, and ensuring ongoing compliance with global regulatory standards.

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:
• o Form MD-12 (Manufacturing License)
• o Form MD-17 (Import License)
• o 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.