Regulatory Strategy & Submission Leadership
Lead all regulatory affairs submissions and technical documentation activities for assigned medical device/IVD products.
Develop regulatory strategies for D&D; outputs, product changes, technical files, WHO-PQ dossiers, and market-specific submissions.
Confirm and document the regulatory pathway for products and submissions, with approval from the QARA Head.
Maintain an updated RA tracker covering submission status, open actions, pending evidence, query status, target dates, and responsible owners.

Technical Documentation & Regulatory Dossier Management
Prepare, review, and maintain regulatory dossiers including MDR/IVDR technical documentation, WHO-PQ dossiers, and India regulatory submission documents.
Review complex regulatory affairs documentation including technical files, performance summaries, verification/validation evidence, risk documentation, and regulatory justification notes.
Ensure product documentation meets WHO requirements and applicable regulatory expectations for completeness, traceability, and evidence adequacy.




Conduct RA gap assessments and coordinate closure of identified documentation, evidence, or compliance gaps.
Ensure final submission packages are accurate, controlled, approved, and aligned with applicable QMS procedures.

WHO Prequalification (WHO-PQ) Management
Lead and manage WHO Prequalification submissions and compliance activities for applicable products.
Prepare, review, and submit WHO-PQ dossiers, evidence packages, corrections, responses, and compliance reports.
Coordinate with WHO evaluators and regulatory bodies on PQ matters, including query responses, corrections, clarifications, and evidence submission.
Track WHO-PQ observations, queries, due dates, commitments, and closure actions until final resolution.

D&D; and Product Lifecycle Regulatory Support
Provide regulatory input to D&D; outputs, design reviews, design changes, design transfer activities, and product lifecycle documentat

📌 Regulatory Affairs Specialist (Bengaluru)
🏢 bigtec Private
📍 Bengaluru