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Regulatory Affairs Specialist

Company: Intellectt INC
Location: Santa Clara
Posted on: November 22, 2022

Job Description:

Role: Senior Regulatory Affairs Specialist Location: Santa Clara, CA - 95054-2807 Duration: 12 Months Shift Timings: 8 AM to 5 PM . Hybrid role in Santa Clara (3 days onsite and 2 days remote) Responsibilities: . Support Medical devices in cardiovascular space . Regulatory Medical device experience in any of the class 3 implantable devices. . Support PMA experience. . Knowledge in US and EU medical device submissions; Regulatory impacts, EU MDR activities: supply changes, manufacturing change, design changes in US and European Union. . Help the international regulatory team with submissions. . Experience supporting internal and external inspections . Experience with continuous improvement activities . Candidates from companies like Medtronics, Stryker, J&J will have experience which will be similar to work here. These candidates will be preferred. Education and Experience: . Bachelors required . 3 to 5 years of experience in Medical Device Regulatory Affairs Top Skills: .PMA experience . Exp writing submission to the FDA. . Practical experience in assessing changes of regulatory impact.

Keywords: Intellectt INC, Santa Clara , Regulatory Affairs Specialist, Other , Santa Clara, California

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