Senior Scientist

Job Summary:
Manage the entire biocompatibility program of current and new product development by working closely with program managers, regulatory and quality teams. Manage both external consultants and CRO’s to meet expectations and timelines for appropriate targeted regulatory document submissions. Time permitted- Conduct research within the chemistry team by working closely with associate scientists and collaborating with others. This is anticipated by guiding research, analyzing gathered data, and providing feedback to develop new products (biosensor) for the next generation CGM (Continuous Glucose Monitoring.

Job Requirements and Responsibilities:

• Prior knowledge in the biocompatibility and biological risk assessments of class III medical devices.
• Have broad spectrum knowledge on the testing requirements based on device classifications (long term implants and external contact devices)
• Ability to work with Consultants, CRO’s and external companies to create biocompatibility risk assessments
• Manage, execute, and coordinate testing for each design, configurational change following the recommendations and guidelines as specified in ISO 10993.
• Review protocols, test results and compile the reports as per regulatory and quality requirements
• Support documentation, write up and coordinate discussions as needed with the external consultants and CRO’s.
• Support R&D in providing toxicological risk assessments for material, design and other changes that need biocompatibility evaluations.
• Perform lab testing, assay development to evaluate device stability and performance to establish safety and efficacy of the device.
• Perform device testing as guided by the teams to create better understanding of the device function.
• Understanding biological testing performed on the current approved devices and be the point of contact to coordinate design, material, processing and manufacturing related changes to approved products.

Knowledge, Skills, and Abilities:

• MS or PhD in polymer, material, chemical, biochemistry, chemistry degree with 3-5 years of experience in understanding biocompatibility and risk assessment of medical devices.
• Excellent interpersonal and motivational skills with ability to collaborate between Chemistry, Process Development, Engineering, Quality and Regulatory departments.
• Knowledge on sterilization of medical devices (ETO based techniques)
• Innovative, hands-on, confident, and clear communicator, with a genuine passion for products and ability of multi-tasking.
• Understanding of FDA regulatory requirements and knowledge on compliance, quality systems are added advantages.

• Prior knowledge in the biocompatibility and biological risk assessments of class III medical devices.
• Have broad spectrum knowledge on the testing requirements based on device classifications (long term implants and external contact devices)
• Ability to work with Consultants, CRO’s and external companies to create biocompatibility risk assessments
• Manage, execute, and coordinate testing for each design, configurational change following the recommendations and guidelines as specified in ISO 10993.
• Review protocols, test results and compile the reports as per regulatory and quality requirements
• Support documentation, write up and coordinate discussions as needed with the external consultants and CRO’s.
• Support R&D in providing toxicological risk assessments for material, design and other changes that need biocompatibility evaluations.
• Perform lab testing, assay development to evaluate device stability and performance to establish safety and efficacy of the device.
• Perform device testing as guided by the teams to create better understanding of the device function.
• Understanding biological testing performed on the current approved devices and be the point of contact to coordinate design, material, processing and manufacturing related changes to approved products