Assistant Manager – Regulatory Affairs & Liaisoning (IVD)

Job Summary:

We are seeking a highly motivated and detail-oriented Assistant/Deputy Manager – Regulatory Affairs & Liaisoning with specialized experience in In-Vitro Diagnostics (IVD), specifically including Rapid Card Tests, CLIA, ELISA, Clinical Chemistry, Hematology and RT-PCR. The ideal candidate will have strong hands-on experience in regulatory filing (DMF, technical documentation, application preparation and follow-up), product licensing, and regulatory liaisoning with national and international regulatory bodies.

Key Responsibilities:

Regulatory Submissions & Filings:

• Prepare and submit Device Master Files (DMF)/Product Dossiers, and Technical Documentation in accordance with CDSCO or applicable regulatory standards.
• Draft, compile, and review regulatory submissions (e.g., CDSCO applications, CE Marking submissions, US FDA if applicable).
• Maintain a deep understanding of IVD regulatory frameworks and documentation requirements for products such as Rapid Diagnostic Kits, CLIA, ELISA, Clinical Chemistry reagents, and RT-PCR kits.

Licensing & Approvals:

• End-to-end handling of license applications, renewals, amendments for IVD kits and instruments with CDSCO.
• Coordinate and follow up with licensing authorities for timely approvals and resolution of queries or objections.
• Ensure compliance with applicable regulatory guidelines under Medical Device Rules (MDR), 2017, and amendments thereof.

Liaisoning:

• Act as the primary point of contact with regulatory authorities.
• Collaborate with internal teams (R&D, Quality, Production) to ensure regulatory compliance from product development through commercialization.
• Attend regulatory audits, inspections, and meetings with external regulatory officials.

Compliance & Documentation:

• Maintain up-to-date knowledge of MDR 2017, IVDR, SAHPRA, NAFDAC, KPPB, ISO 13485, ISO 14971 etc.
• Ensure product labeling, packaging, IFUs (Instructions for Use), and promotional materials comply with applicable regulations.
• Track regulatory changes and advise management on impacts on current and future products.

Required Qualifications:

• M.Sc. in Life Sciences, Biotechnology, Microbiology, Biochemistry or equivalent.
• 6–8 years of proven experience in Regulatory Affairs within the IVD/diagnostics industry.

Preferred Certifications:

• PG Diploma/Certificate in Regulatory Affairs
• Training in ISO 13485 / Internal Auditor Certification