regulatory-affairs-head
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation u
By alirezarezvani · 817 installs
npx skills add alirezarezvani/claude-skills --skill regulatory-affairs-head