Regulatory Affairs Specialist

Cyient; Pune District; On-site; INR 1,900,000 - 2,300,000; Full time

Job summary

Cyient is seeking an experienced regulatory professional to develop and execute regulatory strategies for medical devices in the US and EU markets. You will prepare and submit regulatory filings such as 510(k) and PMA, review labeling and post-market activities, and collaborate across R&D, Quality, Clinical, and Manufacturing to ensure device lifecycle compliance.

The role requires 08+ years experience in the medical device sector with strong knowledge of FDA and EU MDR requirements, UDI, and

Qualifications

• 08+ years of experience in Medical Devices focused on US/EU markets.
• Experience preparing 510(k), PMA, Technical Documentation and Design Dossiers.

Responsibilities

• Develop and execute regulatory strategies for Class I–III devices per US FDA and EU MDR.
• Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers.
• Collaborate with R&D, Quality, Clinical and Manufacturing to ensure lifecycle compliance.
• Assess regulatory impact of changes and maintain proper documentation/notification.
• Support audits, including FDA inspections and Notified Body audits; ensure readiness and timely responses.

Skills

Regulatory strategy

FDA regulatory knowledge

EU MDR knowledge

Cross-functional collaboration

Audits & inspections

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.

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

Roles and Responsibilities

Under general supervision, performs the design, layout, testing, and evaluation of mechanical and electro-mechanical devices or systems. Performs product development activities including drawing board layout and interpretation and implementation of customer specifications and documentation requirements. Provides existing product line support in design activities and/or modification of hardware in production. Conducts engineering studies and may assign work to technical drafting staff. At this level, assignments are moderately complex and require use of initiative and judgment.