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The role involves managing regulatory requirements for medical devices, preparing documentation for agency submissions, and monitoring global regulations. It requires collaboration with various teams to ensure compliance and expedite approvals.
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The Regulatory Affairs Specialist is responsible for developing and executing regulatory strategies for medical devices, preparing submissions, and ensuring compliance with regulations.
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The Sr. Regulatory Affairs Specialist develops regulatory strategies, prepares submissions for medical device approvals, and collaborates with cross-functional teams to ensure compliance with regulations, while managing multiple projects and mentoring junior members.
Top Skills:
Adobe)AnmatAnvisaEu MdrExcelMdsapMedical Device SoftwareMs Suite (WordNmpaPowerPointTga
About Visby
Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world’s first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.
More about our benefits
Visby offers highly competitive health insurance through United Healthcare or Kaiser, including a company-funded HSA option. We also offer flexible paid time off, 10 company holidays, and many other contemporary benefits and perks.
Visby is a proud recipient of the 2023 Cigna Healthy Workforce Designation.
Additional information
We believe that the unique contributions of all Visbees is the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex, gender, pregnancy or related medical conditions, sexual orientation, gender identity or expression, age, disability, medical condition, genetic information, marital status, or military or veteran status.
Full COVID Vaccination Required - Reasonable accommodations for medical or religious reasons considered.
Visby Medical San Jose, California, USA Office
3010 N 1st St, San Jose, CA, United States, 95134
What you need to know about the San Francisco Tech Scene
San Francisco and the surrounding Bay Area attracts more startup funding than any other region in the world. Home to Stanford University and UC Berkeley, leading VC firms and several of the world’s most valuable companies, the Bay Area is the place to go for anyone looking to make it big in the tech industry. That said, San Francisco has a lot to offer beyond technology thanks to a thriving art and music scene, excellent food and a short drive to several of the country’s most beautiful recreational areas.
Key Facts About San Francisco Tech
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- Research Centers and Universities: Stanford University; University of California, Berkeley; University of San Francisco; Santa Clara University; Ames Research Center; Center for AI Safety; California Institute for Regenerative Medicine
