Develop and execute regulatory strategies for the successful development, registration, and commercialization of medical devices in the US
Job Summary
Develop and execute regulatory strategies for the successful development, registration, and commercialization of medical devices in the US.
Manage and review regulatory submissions, including 510(k) premarket notifications, 510(k), De-Novo applications, Pre-submissions, and IDEs.
Stay current with evolving regulatory requirements, industry trends, and best practices, and proactively communicate updates and potential impacts to stakeholders.
Matching Summary
Develop and execute regulatory strategies for the successful development, registration, and commercialization of medical devices in the US.
Salary
$163,000—$221,000 USD
Skills & Requirements
Must-have
Develop and execute regulatory strategies
Provide regulatory guidance and expertise
Manage and review regulatory submissions
Liaise with regulatory authorities (FDA)
Ensure labeling and advertising compliance
Nice-to-have
Collaborate effectively with cross-functional teams
Stay current with evolving regulatory requirements
Establish and maintain stakeholder relationships
Key Requirements
Bachelor's degree in scientific or engineering discipline
Minimum 8 years of regulatory affairs experience
In-depth knowledge of medical device regulations (FDA 21 CFR Part 820, ISO 13485)
Proven track record of successful regulatory submissions (510(k))
Experience interacting with regulatory agencies (FDA, notified bodies)
Working knowledge for SaMD and AI-enabled software medical devices