Director of regulatory affairs Job at Skills Alliance, Irvine, CA

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  • Skills Alliance
  • Irvine, CA

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

Job Tags

Permanent employment, Full time,

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