Senior Regulatory Affairs Specialist – Lingo (on-site)
Core
Senior Regulatory Affairs Specialist supporting product development and regulatory activities to commercialize Class II software medical devices in the US.
Role type
Senior IC Regulatory Affairs Specialist
Builds
Next-generation biosensing technology (Lingo) for personalized healthcare
Domain
Healthcare / Medical Devices / Biosensing
Required skills
Regulatory strategy, FDA QSR knowledge, 510(k)/PMA submission experience, labeling and advertising compliance, SOP development, cross-functional collaboration, problem solving
Preferred skills
Advanced degree in Engineering/Sciences, software medical device experience, 4-6 years regulated industry experience, ability to manage competing priorities
Technologies
FDA QSR, 510(k), PMA
Responsibilities
Provide strategic input on product lifecycle planning and regulatory requirements for Class II software medical devices; Assess documentation acceptability for medical device submissions; Review and analyze labeling, advertising, and promotional materials for compliance; Lead Regulatory Affairs Ad & Promo SOP development; Prepare regulatory applications/submissions to authorities; Evaluate design, labeling, and distribution changes for regulatory impact; Ensure compliance with post-marketing requirements
Seniority
Senior, hands-on IC