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Finish Line Staffing Services
Published
March 30, 2021
Location
MA, North Andover
Category
Default  
Job Type

Description

Our client, a biotech pioneer in organ transplant technologies and therapies, is in immediate need of an experienced Regulatory Affairs Specialist.

Help make a difference in the lives of many.

Job Duties and Responsibilities:

• Prepare and maintain regulatory submissions and registration of complex Class III devices in the US and in international markets.
• Maintain documentation and perform project management tasks, including record keeping and tracking due dates for FDA and international regulatory submissions.
• Assist with the preparation of FDA applications and other international regulatory documents, including EU Technical Files and documentation related to EU MDR certification.
• Assist with vigilance reporting in the US and around the world.
• Serve as liaison with Quality and Engineering team members and provide support with FDA and EU regulations; participation in FDA and notified body audits as required.

Apply
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Contact Us Today!

617-797-6741

333 Wyman Street, Suite 175 Waltham, MA 02451

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