R&D and Regulatory affairs executive

• Support the development and improvement of disposable medical devices, including infusion, dialysis, anaesthesia, catheter, tubing, and related products.
• Assist in product design and development activities, design inputs, design outputs, and design verification and validation documentation.
• Coordinate prototype development, product trials, material evaluation, and testing activities.
• Support evaluation of raw materials, polymers, components, and packaging materials.
• Prepare product specifications, development reports, test protocols, and technical documentation.
• Coordinate with production, QA, QC, tooling, and other departments for product trials and process improvements.
• Assist in investigating product performance issues and implementing corrective improvements.

2. Regulatory Affairs

• Assist in preparation and maintenance of medical device regulatory dossiers and technical files.
• Support product registration, manufacturing licence documentation, amendments, renewals, and regulatory submissions as applicable.
• Maintain documentation in accordance with the Medical Devices Rules, 2017, and other applicable Indian regulatory requirements.
• Support preparation and review of product labelling, instructions for use (IFU), intended purpose, product specifications, and declarations.
• Assist with documentation required for domestic and export markets.
• Monitor applicable regulatory updates and communicate their impact to relevant departments.
• Coordinate regulatory queries, documentation requests, and follow-up activities with internal teams and external consultants.

3. Quality Management System and Compliance

• Support compliance with ISO 13485 and applicable quality management system procedures.
• Assist in maintaining design and development records, risk management files, change-control records, and document-control systems.
• Coordinate with QA for CAPA, non-conformity investigations, audit observations, and corrective actions.
• Support product risk management activities, including identification of hazards and documentation of risk-control measures.
• Assist in preparing documents for internal audits, external audits, regulatory inspections, and customer assessments.
• Ensure that technical and regulatory documents are accurate, traceable, and maintained in their current approved versions.