Sr. Regulatory Associate Lead - Somerville, United States - Insight Global

Insight Global Somerville, United States

2 weeks ago

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 .

To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
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Required Skills & Experience

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

Nice to Have Skills & Experience

Previous experience at Boston Scientific, Stryker, Medtronic, GE, Cardinal Health, or Abbott

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.

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