Medical Device Compliance | Mumbai (WFO)| Mumbai

*Role:* Senior Process Executive (SPE)
*Location:* Mumbai | 5 Days Work From Office
*Notice Period:* Immediate – 15 Days
*Key Responsibilities:*
* Ensure compliance with global regulations (FDA, ISO 13485, MDR)
* Manage regulatory documentation and records
* Support audits, inspections, and compliance reviews
* Collaborate with QA, RA, and Operations teams
* Track compliance updates and regulatory changes
* Assist in risk assessment and quality processes
* Ensure adherence to SOPs and regulatory guidelines
* Identify process gaps and drive improvements

Requirements

*Eligibility:*
* 1–4 years in Medical Device Compliance / Regulatory Affairs
* Bachelor’s in Life Sciences / Pharmacy / Biomedical or related field
* Experience in documentation, audits, and compliance processes
*Preferred Exposure:*
CAPA • Risk Management • Audit Handling • Regulatory Submissions • Compliance Tracking Tools