07 Sep
|
Michael Page
|
Nagpur
07 Sep
Michael Page
Nagpur
About Our Client
Our client is a globally recognized technology-driven organization operating at the forefront of healthcare and diagnostic innovation. With a robust 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 t
📌 Lead - Product Development (IVD & Medical Devices) (Nagpur)
🏢 Michael Page
📍 Nagpur