Senior Regulatory Executive - Medical Device

Location: Makarba, Ahmedabad, Gujarat

Employment Type: Full Time

Key Responsibilities:

• Develop, review, and maintain regulatory documentation in accordance with EU MDR 2017/745, including technical documentation, risk management files, and clinical evaluation reports.
• Conduct gap assessments against EU MDR requirements to identify areas for improvement and support implementation strategies.
• Coordinate with cross-functional teams to gather data and ensure alignment of regulatory submissions with product design and development processes.
• Stay updated on relevant regulatory testing requirements and ensure compliance with applicable standards.
• Support the preparation of Notified Body submissions, responses to queries, and audit readiness.
• Assist in the compilation and submission of US FDA 510(k) dossiers, including predicate device analysis and regulatory strategy...