Senior Compliance & Regulatory Affairs Specialist (Medical Devices)

Job Title : Senior Compliance & Regulatory Affairs Specialist (Medical Devices)

Location : Mumbai

Department : Regulatory Affairs / Quality Assurance

Experience Required : 7–12+ years

Industry : Medical Devices / Healthcare / Pharma

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Job Summary :

The Senior Compliance & Regulatory Affairs Specialist will lead and manage all activities related to BIS (Bureau of Indian Standards) inspections, compliance, product registrations, and application filings for medical devices. The role also includes handling CDSCO (Central Drugs Standard Control Organization) online submissions, licensing, and regulatory documentation to ensure full compliance with applicable Indian medical device regulatory requirements.

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Key Responsibilities :

BIS (Bureau of Indian Standards) Compliance

• Lead the complete BIS certification process for medical devices.
• Manage BIS inspections, audits, and surveillance activities with internal teams and BIS officers.
• Ensure compliance with relevant IS standards, marking requirements, and quality documentation.
• Prepare and maintain all documents required for BIS registration, renewal, and product listing.
• Coordinate with manufacturing, QA, and testing labs for BIS inspections and testing protocols.

BIS Registration & Application Filing

CDSCO Registration & Licensing

Regulatory Compliance & Documentation

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Required Skills & Qualifications :

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Preferred Qualifications :

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Key Attributes :

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Compensation :

Salary and benefits will be discussed during the interview process and will be determined based on the candidate's experience and qualifications.