Biocompatibility Senior Specialist/Engineer III

Duration: 5+ Months (40hrs/weeks)

Job Category: Quality/Regulatory

Industry: Pharmaceutical, biotechnology

Must Have Skill :

1. Experience in the scope of Biocompatibility for products for EUMDR compliance

2. Experience in chemical characterization of materials

3. Knowledge of ISO 10993 series of standards

4. Design Biocompatibility testing strategy to provide efficient delivery of test results for BSI submissions

5. Provide Bio comp risk assessment report based on test results

Nice to have Skills :

1. Experience with BSI submissions for Biocompatibility

2. Experience working with Class III, class II and class I devices

Responsibilities:

Provide Biocompatibility assessment for client vast majority of products falling into the category of Medical Devices, Define applicable Biocompatibility tests to evaluate product compliance to ISO10993 standard, Assure product biocompatibility to comply with EUMDR regulations, Work with outside laboratory on Biocompatibility test definitions and arrangements, Write final Biocompatibility assessment reports.

Qualifications:

BS or MS degree in Biology/Chemistry or equivalent is preferred, Min 5-year experience working in Medical Device industry is a must, Knowledge of ISO10993 is a must, Experience working with test laboratories for Biocompatibility product assessment, Experience working with product development engineering to identify appropriate representative of product families, Excellent writing and communication skills

Shift: - 1st Shift