Lead - Product Development (IVD & Medical Devices)

Michael Page; Nagpur District; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Michael Page is seeking a Lead - Product Development (IVD) for our healthcare client in Nagpur, India. Lead the end-to-end development of diagnostic and medical device products, including localization for international transfers.

The role works closely with R&D, Regulatory Affairs, Quality, Manufacturing and Supply Chain to ensure regulatory compliance (CDSCO, CE, ISO 13485) and on-time delivery. Exceptional leadership and communication are essential.

Qualifications

• Bachelor's or Master's degree in Biomedical Engineering, Biotechnology, Life Sciences, or a related discipline.
• 8-15 years of experience in IVD or medical device product development.
• Strong understanding of regulated healthcare and diagnostic product environments.
• Sound knowledge of quality standards and regulatory frameworks.
• Demonstrated project management and leadership capabilities.
• Experience managing cross-functional stakeholders and multidisciplinary teams.
• Excellent analytical, problem-solving, and communication skills.

Responsibilities

• Lead the complete product development lifecycle for IVD and medical device products.
• Drive localization initiatives for products transferred from international markets.
• Define and manage project plans, timelines, milestones, and deliverables.
• Collaborate closely with R&D, Regulatory Affairs, Quality, Manufacturing, and Supply Chain teams.
• Ensure compliance with regulatory standards including CDSCO, CE, and ISO 13485 requirements.
• Oversee validation activities, compliance testing, and regulatory submissions.
• Build and manage vendor partnerships to support localized manufacturing.
• Support technology transfer, commercialization, and scale-up activities.
• Manage budgets, resources, and continuous cost optimization initiatives

Skills

Project management

Leadership

Regulatory knowledge

Cross-functional collaboration

Analytical problem-solving

Communication skills

Education

Bachelor's or Master's degree in Biomedical Engineering, Biotechnology, Life Sciences, or related

Job description

• Lead innovation in diagnostics and medical devices
• Drive global product localization initiatives

About Our Client

Our client is a globally recognized technology-driven organization operating at the forefront of healthcare and diagnostic innovation. With a strong commitment to quality, regulatory excellence, and cutting-edge research, the company develops solutions that enhance healthcare outcomes while fostering a collaborative and innovation-focused work environment.

Job Description

• Lead the complete product development lifecycle for IVD and medical device products.
• Drive localization initiatives for products transferred from international markets.
• Define and manage project plans, timelines, milestones, and deliverables.
• Collaborate closely with R&D, Regulatory Affairs, Quality, Manufacturing, and Supply Chain teams.
• Ensure compliance with regulatory standards including CDSCO, CE, and ISO 13485 requirements.
• Oversee validation activities, compliance testing, and regulatory submissions.
• Build and manage vendor partnerships to support localized manufacturing.
• Support technology transfer, commercialization, and scale-up activities.
• Manage budgets, resources, and continuous cost optimization initiatives

The Successful Applicant

A successful Lead - Product Development (IVD) should have:

• Bachelor's or Master's degree in Biomedical Engineering, Biotechnology, Life Sciences, or a related discipline.
• 8-15 years of experience in IVD or medical device product development.
• Strong understanding of regulated healthcare and diagnostic product environments.
• Sound knowledge of quality standards and regulatory frameworks.
• Demonstrated project management and leadership capabilities.
• Experience managing cross-functional stakeholders and multidisciplinary teams.
• Excellent analytical, problem-solving, and communication skills.

What's on Offer

• Opportunity to lead strategic product development initiatives in the healthcare sector.
• Exposure to global product transfer and localization programs.
• Chance to work with diverse stakeholders across technology, quality, and manufacturing functions.
• High visibility role with significant impact on business growth and innovation.
• Competitive compensation and career progression opportunities