Job Title : Regulatory Affairs Professional 4

Duration : 12 months (Possible Extension )

Location : Palo Alto CA 94304 (Hybrid)

Experience : 5-8 years.

Knowledge : Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts.

Solid professional judgment and problem solving competence. Improves existing processes and approaches.

Product Registration Experience :

• Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files
• Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files.
• Knowledge of regulatory guidance documents (FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).
• Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, ISO 10993-1 as evidenced by coursework or submissions that required use of each standard

Teamwork and collaboration : Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.

Experience with Business Tools : Proficient in utilizing business tools such as : E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.