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 robust 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.

Skills:- Regulatory affairs and Documentation

📌 RA Lead (Bengaluru)
🏢 Happy Reliable Surgeries
📍 Bengaluru