Audit 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