Executive - Regulatory Affairs (JD) Key Responsibilities

- Technical File Preparation and Product Regulatory Documentation Preparation and maintenance of Technical Documentation/Technical Construction Files (TCF) for ongoing medical device products in accordance with Indian Medical Device Rules (IMDR/MDR 2017) and EU MDR 2017/745 requirements. Preparation and updating of EU MDR technical documentation for ongoing products, Preparation of relevant annexures, gap assessments, and supporting documentation required for the transition/conversion from MDD to MDR. Preparation of regulatory documentation for 12 airway products for current licence applications and product registrations. Coordination with cross-functional teams for collection, review, and compilation of technical and regulatory documents.
- Regulatory Certificates, Licences and Approvals Maintaining and monitoring regulatory certificates, manufacturing licences, approvals, registrations, and related compliance records. Reviewing certificates and licences for validity, renewal requirements, scope, and updated regulatory information. Supporting the Sales/Commercial team in the preparation and compilation of regulatory documents required for tender submissions. Ensuring availability and controlled maintenance of current regulatory certificates and approvals.
- SOP and Regulatory Format Development Preparation, review, and revision of SOPs, forms, templates, and regulatory formats in line with revised regulatory requirements. Revision and implementation of regulatory procedures associated with the MDD-to-MDR transition.



Alignment of regulatory documentation and internal procedures with applicable MDCG guidance documents, EU MDR requirements, and applicable regulatory standards. Identification of regulatory gaps and implementation of necessary updates to existing procedures and templates.
- Cross-Functional Regulatory Support Providing regulatory support to QA, QC, R&D;, Manufacturing, SCM, and other concerned departments for preparation and review of regulatory documents. Reviewing departmental SOPs and documents for compliance with applicable regulatory and quality requirements. Coordinating with concerned departments for document preparation, correction, completion, and timely submission. Conducting regular follow-ups with responsible personnel to ensure regulatory documentation is completed within defined timelines.
- International Product Registration Supporting international medical device product registration activities in accordance with the regulatory requirements of individual countries. Preparing, reviewing, and compiling registration dossiers and supporting documents as per country-specific regulatory requirements. Coordinating with internal departments collection and submission of required documents. Ensuring regulatory documents are appropriately aligned with the registration authority's format, technical requirements,



and submission specifications. Tracking registration documentation, queries, deficiencies, and follow-up actions until completion of the registration process.
- Regulatory Reporting Submit daily, weekly, and monthly updates on regulatory activities, submissions, registrations, and pending actions. Maintain updated regulatory trackers and action plans with timelines and status. Highlight critical delays, gaps, compliance issues, and risks to management. Ensure timely and accurate regulatory reporting.
- Responsibility for Critical Documents Maintain responsibility for the accuracy, completeness, confidentiality, and controlled maintenance of critical regulatory documents. Ensure only approved and current documents are used or submitted. Maintain proper version control, records, backups, and traceability. Ensure critical documents are readily available for audits, inspections, and submissions.
- General Responsibilities & Confidentiality Maintain strict confidentiality of all Company, technical, regulatory, product, customer, and business information and use only authorized systems and channels for handling such information. Comply with Company confidentiality, information security, document control, and applicable regulatory requirements. Complete assigned regulatory activities accurately and within defined timelines, while staying updated on relevant regulations and guidance. Coordinate effectively with internal departments and authorized external stakeholders and promptly report significant regulatory issues, risks, delays, or non-compliances to management.

📌 Regulatory Affairs Executive (Ramanagara)
🏢 BROWNDOVE HEALTHCARE
📍 Ramanagara