RA Lead

20RA Lead (7–8 years) | EU MDR + India (CDSCO) | Medical Devices

Role summary

Lead regulatory strategy and submissions for a medical device portfolio (hardware + software + accessories) across the EU MDR and India (CDSCO), with strong ownership of technical documentation and lifecycle change management.

Key responsibilities

• Own regulatory strategy and submission planning for EU MDR + India; build timelines, evidence plans, and dossier readiness trackers.
• Lead/author EU MDR Technical Documentation (Annex II & III): device description, GSPR checklist, risk/benefit, V&V summaries, clinical evaluation linkage, labeling/IFU, PMS/PMCF plans.
• Drive classification and portfolio mapping; support UDI basics and EMDN/basic UDI alignment (as applicable).
• Manage Notified Body interactions: questions, responses, meeting preparation, evidence packaging, and change justifications.
• Own India lifecycle activities: CDSCO changes (PAC), license maintenance, and regulatory communications.
• Ensure regulatory alignment for standards-driven evidence: ISO 14971, IEC 62304, IEC 60601, IEC 81001-5-1, usability (IEC 62366-1), biocompatibility (ISO 10993), and sterilization/reprocessing (as applicable).
• Support labeling/claims governance: intended use, indications, contraindications, and marketing claims review.
• Build and mentor the RA team; ensure version control, traceability, and audit-ready submissions.

Must-have qualifications

• 7–8 years in regulatory affairs for medical devices (Class II/III exposure preferred).
• Strong experience with EU MDR technical documentation and handling Notified Body queries/submission packages.
• Working experience with the CDSCO regulatory lifecycle (licenses/changes) is strongly preferred.
• Solid understanding of standards-driven evidence for HW+SW devices (14971, 62304, 60601, usability, biocomp).

Nice to have

• Exposure to US FDA 510(k), clinical evaluation/PMCF, cybersecurity documentation, and SaMD claims strategy.
• Experience with complex HW+SW systems and regulated accessories/instruments.