Job Title: Sr. Regulatory Affairs Specialist / Manager
Position Type: Full-Time, General Recruiting
Location: Sunnyvale, California
Salary Range : $80k- $140k base annually on w2
Job ID#: 148164
Summary:
The Sr. Regulatory Affairs Specialist/Manager will oversee medical device development and market introduction, ensuring compliance with regulatory standards for Class I, II, and III devices. This role involves collaborating with cross-functional teams to conduct regulatory pre- and post-market analyses, preparing submissions for FDA 510(k) and EUA applications, and maintaining an ISO 13485-compliant Quality Management System. The specialist will also support government interactions regarding device registrations, manage regulatory assessments for product changes, and ensure compliance with global regulatory requirements throughout the product lifecycle. Strong analytical, communication, and project management skills are essential for success in this role.
Requirements:
About Us:
Founded in 2009, IntelliPro stands as a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. With a dynamic presence in the USA, China, Canada, Singapore, Philippines, UK, India, Netherlands, and Germany, we continue to lead the way in global talent solutions.
IntelliPro, a global leader in connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn moreabout our commitment to diversity and inclusivity at
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