This role is for a Regulatory Affairs Specialist to lead submissions and technical documentation for medical device and IVD products. It involves developing regulatory strategies, managing technical documentation and dossiers, and ensuring compliance with global regulatory requirements, particularly for WHO Prequalification.
Responsibilities
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
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
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
Provide regulatory input to D&D outputs, design reviews, design changes, design transfer activities, and product lifecycle documentation
Ensure D&D documentation is aligned with applicable regulatory pathways and submission requirements
Review Design History File (DHF), Design Transfer File (DTF), validation reports, design change documents, technical justifications, and traceability records from a regulatory perspective
Ensure compliance with MDR/IVDR, ISO 13485, ISO 14971, WHO requirements, and applicable internal procedures
Review risk management documentation and ensure alignment with ISO 14971 and product-specific regulatory expectations
Support audit readiness for regulatory submissions, WHO-PQ reviews, notified body assessments, customer audits, and regulatory inspections
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Support audit handling, nonconformance closure, CAPA follow-up, and regulatory evidence compilation as required
Ensure regulatory commitments, compliance actions, and submission-related corrective actions are tracked and closed in a timely manner
Coordinate with QA, D&D, Manufacturing, Validation, Clinical/Performance Evaluation, Documentation Control, external testing laboratories, and regulatory consultants for regulatory deliverables
Work closely with internal stakeholders to collect, review, and finalize evidence required for technical files, regulatory dossiers, WHO-PQ submissions, and query responses
Provide regulatory guidance to project teams to ensure submission readiness and compliance with applicable requirements
Draft technical summaries, regulatory notes, submission cover letters, memos to file, gap assessment summaries, and compliance justification notes
Maintain submission records, regulatory correspondence, approval evidence, and regulatory communication history in controlled locations
Support urgent regulatory deliverables, audits, and management priorities beyond defined scope when required
Requirements
Bachelor's/Master's degree in Biomedical Engineering, Medical Electronics, Electronics Engineering, or related discipline
8–12 years of Regulatory Affairs/Quality Assurance experience in medical devices/IVDs
Experience in regulatory documentation, technical file preparation, D&D documentation review, audits, and compliance evidence management is required
Strong knowledge of global regulatory requirements including EU MDR/IVDR, WHO requirements, India/CDSCO requirements, and other applicable regulatory expectations
Advanced documentation and technical writing skills for regulatory submissions, technical files, WHO-PQ dossiers, compliance reports, technical justifications, and query responses
Strong understanding of ISO 13485 QMS requirements, documentation control, audits, change control, nonconformance, CAPA, and regulatory evidence expectations
Risk management expertise with working knowledge of ISO 14971 and risk file requirements for medical devices/IVDs
Deep understanding of Design & Development controls, DHF/DTF documentation, verification/validation evidence, performance evaluation, design changes, and technical file maintenance
Ability to perform RA gap assessments and convert gaps into clear action plans with owners, timelines, and evidence requirements
Audit handling, nonconformance closure, and cross-functional coordination skills
Nice to have:
Regulatory Affairs certification
Experience in WHO Prequalification or international regulatory submissions
