Position - Sr. Regulatory Affairs Manager
Location - Sunnyvale, CA
Full time
Salary - $100k - $150k + Benefits
Qualifications
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 510(k) 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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