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Regulatory Affairs Associate

Santa Clara, CA 95054

Posted: 04/03/2025 Employment Type: Contract Job Category: Scientific Job Number: 618823 Is job remote?: No Country: United States

Job Description

Description:
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.

Pay ranges between $35-40/hr based on experience 

 
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About Santa Clara, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area around Santa Clara, California. Located in the heart of Silicon Valley, this region offers unparalleled growth opportunities in tech, innovation, and beyond. With attractions like Levi's Stadium, the Santa Clara Convention Center, and the nearby California's Great America theme park, there's always something exciting to do. Indulge in the diverse culinary scene, catch a show at the Triton Museum of Art or the historic Santa Clara Theatre, or cheer for the San Francisco 49ers at Levi's Stadium. Discover why Santa Clara is the perfect place to elevate your career and enjoy a rich blend of culture and charm!

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