· 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.
· Global regulatory experience or knowledge is added advantage.
· 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.
· 08+ years of experience, specifically focused on Medical Devices in the US and EU markets

📌 Regulatory Affairs Specialist (India)
🏢 Cyient
📍 India