Job Description
Position - Sr. Regulatory Affairs Manager
Location - Sunnyvale, CA
Full time
Salary - $100k - $150k + Benefits
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.
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