Job Description
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...