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
Positive English writing and documentation skills

Positive 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 (India)
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📍 India