Job Requirements

About the Role

Seeking an experienced Regulatory Affairs Professional to lead / manage regulatory compliance activities for our Medical Device and In-Vitro Diagnostic (IVD) manufacturing operations. The ideal candidate will have robust expertise in Indian & international medical device regulations, regulatory submissions, quality management systems & liaison with government authorities & certification bodies.

The role requires a proactive professional who can ensure complete regulatory compliance while supporting new product registrations, manufacturing license approvals, market expansion initiatives, and continuous compliance with applicable standards and regulations.

Key Responsibilities

Regulatory Affairs & Licensing

• Prepare, review & submit applications for: Manufacturing licenses for IVD assays, consumables & related products. Product registrations & approvals with CDSCO and State FDA authorities. Amendments, renewals & regulatory variations as applicable. Ensure compliance with Medical Devices Rules (MDR) 2017 & related regulatory requirements.




• Act as the primary point of contact with CDSCO, State FDA & other regulatory authorities.
• Respond to regulatory queries, deficiency letters, inspections & audits.

International Regulatory Compliance

Coordinate and support regulatory filings and approvals for: CE Marking/ US FDA submissions/ MDSAP requirements/ WHO-related applications and registrations

Quality & Compliance Management

Ensure continued compliance with: ISO 13485/ ISO 9001, MDR 2017 Applicable national and international regulatory requirements. Support internal, external, certification, customer, and regulatory audits & collaborate with R&D;, QA & Operations teams to maintain regulatory compliance.

Qualifications: Bachelor's / Master’s degree in: Pharmacy/ Life Sciences/ Microbio/ Biotechnology/Regulatory Affairs

Experience

• Minimum 8-12 years of relevant experience in RA within: In-Vitro Diagnostic (IVD) Manufacturing
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