Regulatory Affairs Specialist

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 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.

Risk Management, Audit, and Compliance Support

• 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.
• 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.

Cross-Functional Coordination

• 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.

Additional Responsibilities

• 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.

Education

• Bachelors/Masters degree in Biomedical Engineering, Medical Electronics, Electronics Engineering, or related discipline.
• Regulatory Affairs certification is optional but preferred.

Experience

• 8–12 years of Regulatory Affairs/Quality Assurance experience in medical devices/IVDs.
• Experience in WHO Prequalification or international regulatory submissions is preferred.
• Experience in regulatory documentation, technical file preparation, D&D documentation review, audits, and compliance evidence management is required.

Technical Skills

• 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.