Product Manager - IVD (PhD Mandatory)

Product Manager / Product Specialist In Vitro Diagnostics (IVD)

Location: Chennai (Abhirampuram)

Experience: 3–5 Years

Qualification: PhD – Mandatory

Travel: Willingness to travel domestically and internationally (up to 25%)

Job Summary

We are looking for a technically strong and self-driven Product Manager / Product Specialist with a PhD in Life Sciences or a related discipline and 3–8 years of relevant experience in the In Vitro Diagnostics (IVD) industry.

The candidate will support global product management activities, product lifecycle management, regulatory compliance, quality documentation and technical support for the IVD product portfolio.

Key Responsibilities

• Manage and maintain product-related documentation in compliance with ISO 13485, MDSAP, IVDR and applicable regulatory requirements.
• Develop, review and maintain SOPs, work instructions, forms, templates and controlled documents.
• Coordinate with Regulatory Affairs, Quality Assurance, R&D, Manufacturing, Marketing and Sales teams.
• Support regulatory technical documentation throughout the product lifecycle.
• Handle Post-Market Surveillance (PMS), customer complaints, feedback analysis, CAPA and risk management documentation.
• Provide technical and product-related support to global customers, distributors and internal sales teams.
• Support product launches, product improvements and technical issue resolution.
• Prepare technical presentations, product brochures, scientific reports and product performance summaries.
• Participate in internal and external audits and support regulatory compliance activities.
• Analyse market requirements, product performance and customer feedback.

Mandatory Requirements

• PhD in Biochemistry, Biotechnology, Life Sciences, Molecular Biology, Immunology or a related discipline.
• 3–5 years of relevant experience in the In Vitro Diagnostics (IVD) industry.
• Hands-on exposure to IVD Product Management and/or product lifecycle activities.
• Strong understanding of Quality Management Systems (QMS), ISO 13485 and IVDR requirements.
• Experience in regulatory documentation and compliance.

Additional Requirements

• Excellent technical documentation and communication skills.
• Ability to work independently and coordinate with cross-functional teams.
• Willingness to travel domestically and internationally (up to 25%).
• Comfortable working with global teams across different time zones.
• Self-driven, dedicated and customer-focused professional.

Candidates meeting the mandatory PhD and IVD industry experience requirements are encouraged to apply.