Job Description

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

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