*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
* 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