Regulatory Affairs Specialist

·        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