Medical Device Biocompatibility Specialist
3 weeks ago
We are seeking a highly skilled Medical Device Biocompatibility Specialist to join our team at IF MedTech Pvt Ltd in Navi Mumbai. This role is dedicated to ensuring the safety and efficacy of our medical devices through cutting-edge design, development, and pilot manufacturing.
About the RoleThe successful candidate will be responsible for performing toxicological risk assessments (TRA) as per ISO 10993-17 and ISO 10993-18, calculating Margin of Safety (MoS), Acceptable Daily Intake (ADI), and Permissible Daily Exposure (PDE) to determine safe exposure limits for substances released from devices. They will also assess potential health risks posed by chemical compounds released from medical devices.
- Prepare and maintain Biological Evaluation Reports (BER) ensuring compliance with global regulatory standards.
- Collect comprehensive and scientifically validated documentation for BER.
- Recommend and implement effective solutions to address identified deficiencies in BER and TRA.
The ideal candidate will have a Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Electronics) or a related technical field, minimum 1 year of experience in 10993-17 and ISO 10993-18 within the medical device industry, strong communication and teamwork skills, detail-oriented with a focus on quality and compliance, and knowledge of materials used in medical devices, especially biocompatible and durable materials.
What We OfferWe offer a competitive salary range of ₹8,50,000 - ₹10,50,000 per annum, depending on experience and qualifications, a dynamic and collaborative work environment, opportunities for professional growth and development, and a chance to contribute to the revolution of healthcare through innovative medical device design and development.
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