Quality Assurance Executive

*HIRING – JUNIOR REGULATORY & QMS EXECUTIVE – MEDICAL DEVICES* *We are looking for a Junior Regulatory & QMS Executive for our Mumbai-based client.* *Location:* Mumbai *Work Mode:* Hybrid *Travel:* 50–60% Pan India *Experience:* 1–3 years preferred *CTC:* ₹2.5–4.0 LPA *Special consideration:* Candidates with *ISO 13485:2016 Lead Auditor qualification + hands-on regulatory compliance experience* may be considered up to *₹4.5 LPA*. ### About the Role The candidate will support Medical Device QMS and regulatory compliance projects, work with clients across India, and assist senior consultants in QMS implementation, audits and regulatory documentation. ### Key Responsibilities * Prepare and revise SOPs, procedures, forms, formats and QMS documents * Support *ISO 13485:2016 QMS implementation and maintenance* * Maintain client-wise QMS trackers, records and compliance activities * Assist in *Internal Audits, CAPA, Management Review, Training and Supplier Evaluation* * Support preparation/review of *Technical Files, Risk Management, GSPR, IFU, Labels and regulatory documents* * Conduct basic regulatory research under guidance * Follow up with clients for pending documents, records and corrective actions * Prepare meeting notes, checklists, reports and consultancy documents * Support senior consultants during client meetings, projects and audits ### Qualification * B.Pharm / M.Pharm * Biomedical / Biotechnology / Life Sciences * Or other relevant qualification ### Experience * 1–3 years preferred in *Medical Devices / Pharma QA / Regulatory / ISO QMS* * *Good freshers may also be considered* * Candidates with ISO 13485:2016 Lead Auditor qualification and hands-on regulatory compliance experience may be considered for higher CTC. ### Required Skills * Good English writing and documentation skills * Good knowledge of *MS Word and Excel* * Attention to detail and good document-control practices * Good communication and follow-up skills * Ability to manage multiple client assignments * Willingness to learn ISO 13485 and Medical Device Regulations * Ability to work independently after guidance * Willingness to travel extensively across