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 * Valuable 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

📌 Audit Executive (Mumbai)
🏢 Spectra7 HR Solutions and Consultancy
📍 Mumbai