Regulatory Analyst

3 weeks ago

Pune India Cyient Full time

Job Description - Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). - Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. - Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. - Assess the regulatory impact of product and process changes and ensure proper documentation and notification. - Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings. - Review and approve product labeling, IFUs, and promotional materials for compliance with US and EU regulations. - Ensure compliance with Unique Device Identification (UDI) requirements and support EUDAMED submissions. - Provide regulatory oversight for post-market surveillance, vigilance reporting, and adverse event investigations. - Liaise with regulatory authorities including FDA and Notified Bodies, managing communications and submissions. - Mentor junior regulatory team members and provide training on evolving regulatory requirements and best practices. - 4+ years of experience, specifically focused on Medical Devices in the US and EU markets

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