: Regulatory Affairs Lead

Responsibilities:

· 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 the 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.

· 7+ years of experience, specifically focused on Medical Devices in the US and EU markets

Job Requirements:

Education

· Bachelor/Master’s degree in either Mechanical or Electrical engineering or equivalent) from an accredited university

· 7+ years minimum of experience in a Regulatory Affairs role in a Product Development/Sustaining Engineering setting

Job Location: Hyderabad, India

📌 Regulatory Affairs Specialist (Hyderabad)
🏢 Cyient
📍 Hyderabad