Insight Global is actively seeking a skilled Risk Management Subject Matter Expert (SME) with a strong background in the Medical Device industry. This is a fully remote and long term opportunity 3+ years - As part of our team, you will play a crucial role in supporting EU MDR remediation projects across various scopes and complexities. Conduct comprehensive gap assessments of existing usability and risk management documentation against EU MDR requirements and relevant standards (such as ISO 14971:2019 and IEC 62366-1:2015). Collaborate with cross-functional teams, including internal design and development, regulatory affairs, medical affairs, and manufacturing engineering partners. Plan, organize, execute, and report on usability and risk management activities. Provide risk management leadership, expertise, guidance, and supervision throughout the remediation project. Develop efficient and robust processes, procedures, practices, tools, and technology to enhance risk management practices. Lead the development and implementation of key performance indicators (KPIs) and metrics for the risk management process.
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.
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
https://insightglobal.com/workforce-privacy-policy/ .
5+ years experience within Medical Device industry (Classes I-III) as subject matter expert for Risk Management (ISO 14971:2019 + IEC 62366-1:2015) .
Experience with product focused EU MDR remediation projects, Usability Engineering, and Risk Management processes, procedures, etc for continuous improvement.
Expertise in the application of statistical techniques to support the calculation of probabilities of hazardous situations occurring.
Bachelors Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical, etc).
Background with Design Quality / Design Quality Assurance for Medical Devices (Class I, II, III).
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.