Regulatory Affairs Specialist Job in Pune – Medical Devices

Are you an experienced Regulatory Affairs Specialist looking to accelerate your career in the medical devices industry? Cyient is hiring an Associate-level professional in Pune with expertise in US FDA 21 CFR 820, EU MDR 2017/745, and global regulatory submissions. This role offers the opportunity to lead regulatory strategy, drive compliance, and work closely with R&D, Quality, Clinical, and Manufacturing teams.

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Key Responsibilities

As a Regulatory Affairs Specialist, you will:

• Develop and execute regulatory strategies for Class I, II & III medical devices for US and EU markets.
• Prepare, review, and submit 510(k), PMA, Technical Documentation, and Design Dossiers.
• Collaborate with R&D, Quality, Clinical, and Manufacturing teams throughout product lifecycle.
• Assess regulatory impact of product/process changes and prepare required documentation.
• Support internal/external audits including FDA inspections and Notified Body audits.
• Review and approve product labeling, IFU, and promotional materials per regulations.
• Ensure compliance with UDI requirements and support EUDAMED submissions.
• Provide oversight for post-market surveillance, vigilance reporting, and adverse event handling.
• Communicate with regulatory authorities—FDA, Notified Bodies, and other agencies.
• Mentor junior team members and provide training on changing regulatory requirements.

Required Qualifications

• 8+ years of experience in Regulatory Affairs for medical devices.
• Strong expertise in US FDA regulations (21 CFR Part 820) and EU MDR (2017/745).
• Hands-on knowledge of 510(k), PMA, TD, DD submissions.
• Experience in global regulatory requirements (advantage).
• Strong documentation, communication, and audit-readiness skills.

Location

📍 Pune, Maharashtra, India

Benefits & Why Join Cyient

• Opportunity to work with global medical device regulatory frameworks.
• Exposure to multidisciplinary teams across R&D, QA, and Clinical.
• Competitive salary aligned with industry standards.
• Career growth and leadership opportunities.

How to Apply

Application Link