Senior Compliance & Regulatory Affairs Specialist (Medical Devices)

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Experience Required:

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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

• Handle end-to-end registration on BIS portals (MANAK Online) for medical devices.

• Prepare, review, and file BIS application forms, including Form I, Form II, test reports, and technical files.

• Monitor application status, respond to queries, and ensure timely approval.

• Maintain all BIS documentation, certificates, and compliance records.

CDSCO Registration & Licensing

• Handle CDSCO application filings for medical devices (MD-5, MD-14, MD-15, MD-16, etc.).

• Prepare, review, and submit required dossiers including Plant Master File (PMF), Device Master File (DMF), QMS certificates, and technical documentation.

• Manage communication with CDSCO officials/Notified Bodies.

• Ensure compliance with Medical Device Rules (MDR) 2017 and related guidelines.

• Maintain all regulatory submissions, approvals, and licenses in an organized manner.

Regulatory Compliance & Documentation

• Ensure products meet India’s regulatory and statutory requirements.

• Update internal teams on regulatory changes in BIS, CDSCO, and medical device standards.

• Prepare SOPs, audit documentation, and regulatory reports.

• Support internal and external audits (ISO 13485, BIS, CDSCO, etc.).

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Required Skills & Qualifications:

• Bachelor’s or Master’s degree in Biomedical Engineering, Pharmacy, Life Sciences, or related field.

• 7–12+ years of experience in Medical Device Regulatory Affairs.

• Strong expertise in BIS certification, inspection handling, and application filing.

• Hands-on experience with CDSCO filing portals, import/manufacturing licenses, and compliance.

• Deep understanding of MDR 2017, BIS Act/Rules, and Indian regulatory framework.

• Excellent documentation, communication, and coordination skills.

• Ability to manage regulatory projects independently with minimal supervision.

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Preferred Qualifications:

• Experience working with Class A/B/C/D medical devices.

• Familiarity with international standards (ISO 13485, IEC standards).

• Prior experience engaging with regulators and testing labs.

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Key Attributes:

• Detail-oriented and highly organized.

• Strong problem-solving and process management skills.

• Ability to handle multiple regulatory projects simultaneously.

• Leadership skills for guiding junior regulatory team members.

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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.