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Director of Regulatory Affairs and Compliance

2 months ago

Irvine, California, United States Skills Alliance Full time

Job Title: Director of Regulatory Affairs and Compliance

Job Type: Permanent

Location: Hybrid

About the Role:

Skill Alliance is seeking a seasoned Director of Regulatory Affairs and Compliance to lead our regulatory strategy and ensure compliance with global regulations. As a key member of our senior leadership team, you will be responsible for developing and executing regulatory plans to bring our innovative medical devices to market.

Key Responsibilities:

  • Develop and Execute Regulatory Strategies: Collaborate with cross-functional teams to develop and execute global regulatory strategies for new and existing medical devices.
  • Regulatory Approvals: Lead the submission process for regulatory approvals, including FDA, CE Mark, and other international regulatory bodies.
  • Regulatory Compliance: Ensure regulatory compliance throughout the product lifecycle by collaborating with R&D, Quality Assurance, and Manufacturing teams.
  • Quality Support: Support the Quality team during internal/external audits and provide regulatory expertise as needed.
  • Clinical and Commercial Support: Support Clinical and Commercial functions in post-market vigilance and clinical follow-up activities, including related regulatory reporting.
  • Regulatory Expertise: Act as the Regulatory Representative as defined by EU MDR.

Requirements:

  • Education: Minimum BSc in a relevant field, MSc or PhD preferred.
  • Experience: 10+ years' experience within regulatory affairs in the medical device industry.
  • Regulatory Expertise: Expert knowledge of ISO 13485, 14971, 21 CFR 820, EU MDR.
  • Leadership Experience: Leadership experience is preferred, with a track record of building and leading high-performing teams.
  • Technical Skills: Experience working with software and hardware components, and understanding of clinical evaluation and investigation.