Insight Global is seeking a Technical File Reviewer (Product Assessor) to join the business assurance group for one of our Inspection and Certification clients. This position will be responsible for conducting comprehensive assessments of soft tissue medical devices through reviewing technical files. During this process, this person will focus heavily on the electronics of each product and ensure that technical files adhere to requirements outlined in European Medical Device Directive and Medical Device Regulation for Class I/ IIa /IIb and/or Class III medical devices. 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 [email protected] . To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: . Required Skills & Experience Bachelors degree in Science or Engineering (preferably electrical engineering) 5+ years of experience in designing, manufacturing, or testing medical devices Knowledge of European medical device standards and regulations (93/42/EEC, 2017/745) Experience with medical devices incorporating software / utilizing software / controlled by software (MDS 1009) Excellent communication skills through electronic mediums Nice to Have Skills & Experience Experience conducting product assessments for another certification organization Previous experience with soft tissue products 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. Insight Global
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