Medical Device Compliance | Mumbai (WFO)| Mumbai

Company : 2coms

Job Type : Full Time

Job Description - 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

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