Job Description

Our large medical device client is looking for a Sr. RA Lead to join their team and assist with a backlog of projects. This individual will be helping with a portfolio of class III medical devices and helping the manufacturing site with necessary change assessments. They will draft regulatory changes and submissions for these class III products, notify world affiliates of changes, mentor jr. RA associates, and partner on RA pathways on respective countries. This role will sit remotely and the contract is starting at 12 months with possibility of extension.

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/ .

Skills and Requirements

-Understanding of change assessments for class III products

-Experience with PMA products

-Experience making change assessments for EU, US, and rest of world

-Experience reviewing marketing material and clinical reports

-Ability to navigate change control systems

-Bachelor's Degree -Previous experience at Boston Scientific, Stryker, Medtronic, GE, Cardinal Health, or Abbott null

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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to 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 oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.