We are seeking a Biocompatibility Specialist for a large medical device manufacturing client. The Biocompatibility specialist is a remote opportunity that is required to work EST hours.
Responsibilities:
Planning and execution of biological safety evaluations of materials and medical devices according to ISO-10993 and applicable regulatory requirements.
Work with site staff to locate and review existing product documentation in respect to Biocompatibility, Manufacturing Processes, Sterilization, Packaging and/or Cleaning Validation information.
Understand and identify possible gaps for ISO 10993-1 and support ISO 10993 testing where needed.
Design, initiate, coordinate, and interpret (contract) laboratory investigations for biocompatibility testing of medical devices. Ensure all testing meets the ISO, FDA, CDRH, and GLP requirements.
Compile/write/review/approve Biocompatibility Test Plans, Test Reports and Biological Safety Risk Assessments in support of Technical File and FDA submissions.
The rate for this position ranges from $63/HR to $70/HR depending on skillset, education and experience.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
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At least 1 year of experience as a Biocompatibility specialist or related role
Experience working at a medical device manufacturer
In-depth knowledge of ISO 10993-1 and related standards.
Strong writing skills for drafting biological evaluation reports and test protocols. Ability to produce coherent and comprehensive documents without extensive review by staff engineers
Experience in coordinating with external labs for biocompatibility testing.
Ability to independently plan and push tests to completion, managing communication with external suppliers.
Experience in pushing projects to 510(k) submissions, including new product development and project submissions.
Experience working in a Contract Research Organization (CRO)
Experience in medical device manufacturing, especially with metallics and implants, is highly desirable.
Toxicology experience, particularly knowledge of ISO 10993-17 and ISO 10993-18
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.