Job title: Director of Regulatory Affairs - Medical Devices
Job type: Permanent
Location: Irvine, CA (hybrid)
An innovative privately held medical device firm is looking for a Director of Regulatory Affairs. They are dedicated to enhancing the quality of life of patients with their cutting-edge critical care platform. The organization are expanding their senior leadership team and are looking for a strategic leader. This is a pivotal role in leading the regulatory strategy to ensure all products comply with global regulations and reach the market with the highest standards of safety and quality.
Responsibilities:
Develop and execute global regulatory strategies for new and existing medical devices
Lead the submission process for regulatory approvals, including FDA, CE Mark, and other international regulatory bodies: US FDA IDE, 510(k), CE Marking
Collaborate with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to ensure regulatory compliance throughout the product lifecycle
Support the Quality team during internal/ external audits
Supports Clinical and Commercial functions in post-market vigilance and clinical follow-up activities, including related regulatory reporting
Act as the RRP as defined by EU MDR
Requirements:
Minimum BSc in relevant field, MSc or PhD preferred
10+ years' experience within regulatory affairs in the medical device industry
Experience authoring 510(k) and technical file submissions
Leadership experience is preferred, building out teams
Experience working with software and hardware components
Understanding of clinical evaluation and investigation
Expert knowledge of ISO 13485, 14971, 21 CFR 820, EU MDR.
Renal experience is preferred
For further information please reach out to emily.james@skillsalliance.com or call +1 (646) 889-8093