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REGULATORY AFFAIRS LEAD – MEDICAL DEVICES
Diverse Lynx India
🇺🇸 United States
On-site
Staff / Principal
1 month ago
- Regulatory Compliance
- Risk Management
1 month ago
Not enough detail in this posting to match
Position: Regulatory Affairs Lead
Experience: 7-9 Years
Location: Bengaluru / Hybrid
Function: Quality & Regulatory Affairs
Industry: Medical Devices / MedTech
Reports To: QARA Practice Lead
POSITION SUMMARY:
We are seeking a highly motivated Regulatory Affairs Lead with 7-9 years of experience in the Medical Device industry to lead global regulatory activities and ensure compliance across the product lifecycle. The individual will play a key role in regulatory strategy, submissions, market access, design change assessments, and regulatory compliance for Class I, II, and III medical devices.
The role requires extensive knowledge of FDA regulations, EU MDR, ISO 13485, ISO 14971, global product registrations, and post-market regulatory requirements.
KEY RESPONSIBILITIES
• Develop and execute global regulatory strategies.
• Lead FDA 510(k), PMA, De Novo, EU MDR, UKCA, Health Canada and international registrations.
• Prepare and review Technical Documentation, Technical Files and Design Dossiers.
• Support Design Controls, change assessments and lifecycle management.
• Ensure labeling, IFU and UDI compliance.
• Collaborate on Risk Management activities as per ISO 14971.
• Support CER, PMCF and clinical evidence generation.
• Lead Post-Market Surveillance, Vigilance and adverse event reporting activities.
• Liaise with notified bodies, regulatory agencies and auditors.
• Mentor junior regulatory professionals and drive process excellence.
REGULATORY AFFAIRS LEAD – MEDICAL DEVICES · Diverse Lynx India