Experience: 6 to 10 years in medical devices QA and RA

Qualification: M.Sc./M.Pharm

Quality Assurance

 Maintain and implement QMS procedures in accordance with ISO 13485:2016

 Support compliance with EU MDR 2017/745 requirements

 Prepare and maintain technical documentation file as per EU MDR 2017/745

 Handle CAPA, nonconformities, deviations, complaints, and change controls.

 Conduct internal audits and coordinate customer, certification-body, and regulatory audits.

 Support post-market surveillance, vigilance, and complaint-handling activities as applicable.

 Ensure proper document and record control throughout the product lifecycle.

 Other QA related duties as assigned.

Regulatory Affairs

 Prepare, review, and maintain regulatory submissions.

 Coordinate product registration, licensing, renewals, amendments, and variations with regulatory authorities.

 Prepare responses to questions,



deficiencies, and requests for additional information from regulatory authorities and conformity assessment bodies.

 Maintain regulatory databases, licenses, certificates, approvals, and submission records.

 Support regulatory audits and inspections and provide relevant documentation.

 Other RA related duties as assigned

Key Skills

 Capable of handling QA and RA related activities independently.

 Solid QA and regulatory documentation skills

 Good interpretation of medical-device regulations

 Technical writing and dossier preparation

 Good communication and coordination skills

 Strong MS Office/document-management skills

 Sound knowledge of ISO 13485, EU MDR 2017/745, GMP.

📌 Sr. Executive QA/RA (Vadodara)
🏢 Surni Labs
📍 Vadodara