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Experienced Regulatory Executive Maven Profcon Services

1 - 2 years

3 - 4 Lacs

Ahmedabad

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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 o...

Posted 5 months ago

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