SantaClaraRecruiter Since 2001
the smart solution for Santa Clara jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Santa Clara RSS job feeds