Product Specialist / Manager - IVD (PhD Mandatory)

Trivitron Healthcare; Chennai; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Trivitron Healthcare is seeking a technically strong Product Manager / Product Specialist for the In Vitro Diagnostics (IVD) portfolio in Chennai. A PhD in Life Sciences or related discipline with 3–8 years of IVD experience is required.

The role involves regulatory compliance, quality documentation, and cross-functional collaboration with R&D, Regulatory, QA, Manufacturing, Marketing and Sales. Responsibilities include lifecycle management, PMS handling, audits, and global technical support.

Qualifications

• PhD in Life Sciences or related field
• 3–5 years of 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

Responsibilities

• Manage 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
• Analyze market requirements, product performance and customer feedback

Skills

Technical documentation

Communication skills

Cross-functional coordination

Travel readiness

Education

PhD in Life Sciences or related field

Job description

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.