Sr Director/Director, Regulatory Affairs

May 21

Apply Now
Logo of Delfi Diagnostics

Delfi Diagnostics

Saving lives through early cancer detection

11 - 50

💰 $225M Series B on 2022-07

Description

• Implement global Regulatory Affairs strategies, policies, objectives, and submissions • Lead the Regulatory function including hiring, performance management, and career development • Support robust FDA quality systems • Prepare and coordinate the preparation of regulatory submissions • Build relationships with Operations, R&D teams, Technical teams, and Commercial • Participate in cross-functional teams • Facilitate and support the achievement of key corporate goals • Achieve key milestones across multiple IVD product development projects • Help implement systems and processes needed to develop and launch IVD products

Requirements

• Bachelor's degree in Engineering, Technology, or other life science degree • 10+ years in regulatory activities, implementation, and compliance experience in the medical device industry • 5+ years of medical device software experience, preferred • Experience with PMA submissions • Strong understanding of 21 CFR 820, ISO 13485, Good Clinical Practice, and other applicable global regulations related to in vitro diagnostics (IVD) and clinical studies • Working knowledge and experience in various regulatory areas such as Quality System Management, US and OUS Regulatory, Document Control, Design Control, Design V&V and Process Validation, Design Transfer, Risk Management, Complaint handling, Vigilance Reporting, CAPA management, Supplier Control, etc. • Demonstrated ability to effectively lead facility inspections conducted by Regulatory Agencies • Demonstrated ability to effectively manage and lead a Regulatory function • Demonstrated ability to successfully work with individuals and in a cross-functional team environment. • Knowledgeable in CLIA/CAP and laboratory developed test (LDT) requirements • Expertise in next-generation sequencing techniques in high-throughput settings • Experience with software in medical device settings

Benefits

• 11 paid holidays • Generous Accrued Time Off • Generous paid sick time • Annual day of service

Apply Now
Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or lior@remoterocketship.com