Regulatory Affairs Manager
Position - Sr. Regulatory Affairs Manager
Location - Sunnyvale, CA
Full time
Salary - $100k - $150k + Benefits
Bachelor’s degree in Science, Engineering, Math, a medical field, or an equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving.
Roles and Responsibilities
Can be independently responsible for 510(k) submissions
In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction.
● You will work closely with Quality, Engineering, Product Management, Marketing, and Sales teams to perform regulatory pre- and post-market analysis, and implement and maintain an ISO 13485 and FDA compliant Quality Management System.
● Participate in the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities.
● Support government interactions pertaining to medical device registrations and licensing;
● Participate in the development of regional regulatory strategy and update strategy based on regulatory changes.
● FDA 510k and EUA application
● Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle.
● Support regulatory activities required for MDR compliance.
Requirements
A minimum of 5 years of experience in medical device Regulatory Affairs, showcasing a comprehensive understanding of regulatory frameworks.
Demonstrated ability to manage small projects, displaying exceptional organization, independence, and outcome-driven focus.
Outstanding analytical and communication skills, paired with a strong sense of teamwork and meticulous attention to detail.
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 more about our commitment to diversity and inclusivity at https://intelliprogroup.com/.
Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, IntelliPro provides a comprehensive benefits package, all subject to eligibility