Regulatory Affairs Specialist

Cyient Limited; Hyderabad; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Cyient Limited is seeking a Regulatory Affairs Lead to develop and execute regulatory strategies for Class I–III medical devices in the US and EU. You will prepare and submit submissions, review labeling and promote materials for compliance, and collaborate across R&D, Quality, Clinical and Manufacturing.

You will assess the regulatory impact of changes, support audits, ensure UDI/EUDAMED readiness, and mentor junior staff while ensuring timely regulatory responses.

Qualifications

• 7+ years of experience in Regulatory Affairs for medical devices.
• Experience with US FDA (21 CFR Part 820) and EU MDR.
• Experience in product development or sustaining engineering.

Responsibilities

• Develop and execute regulatory strategies for medical devices for US and EU.
• Prepare, review, and submit regulatory submissions (510(k), PMA, technical docs).
• Collaborate with R&D, Quality, Clinical, and Manufacturing to ensure compliance.
• Assess regulatory impact of design changes and document appropriately.
• Support audits including FDA inspections and Notified Body audits.
• Review labeling, IFUs and promotional materials for regulatory compliance.
• Ensure compliance with UDI and support EUDAMED submissions.
• Oversee post-market surveillance, vigilance reporting and defect investigations.
• Liaise with FDA and Notified Bodies; manage submissions and communications.
• Mentor junior team members on evolving regulatory requirements.

Skills

Regulatory affairs

Medical devices

US FDA

EU MDR

Cross-functional collaboration

Regulatory submissions

Education

Bachelor’s or Master’s degree in Mechanical or Electrical Engineering

Job description

Job Description: 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 environment

Job Location: Hyderabad, India

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.