Medical devices regulation expert

Has authority / professional authority regarding submissions to regulatory authorities, especially FDA.
Management of regulatory projects in medical devices, guidance and professional training of the staff, writing, and approval of regulatory submissions, writing and approval of regulatory and clinical strategies.

Requirements:
Regulatory expert in medical devices, who has successfully completed at least 15 submissions to the FDA of products in Class 2 & 3/ De-Novo / PMA

Proven experience in writing clinical evaluations, writing a clinical strategy combined with a regulatory strategy, defining required verification and validation tests for the product, and writing PMS and PMCF plans and reports.

Advantage - proven knowledge and experience in IVD and Digital Health devices as well as submissions according to EU-MDR.