Regulatory Affairs Specialist

Role overview

Regulatory Affairs Specialist at Cyient

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

Required qualifications

• 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 environment

Employment details

• Job Location: Hyderabad, India