Quality & Regulatory Manager

Job Summary

A company is looking for a Quality & Regulatory Manager.

Key Responsibilities

• Manage a Lean and compliant Quality Management System for medical devices schemes
• Oversee internal and external audits and maintain regulatory compliance
• Develop and manage the Quality & Regulatory team, ensuring effective performance and training

Required Qualifications

• Higher education qualification (Masters/Ph.D./B.Sc. (Hons) Degree) in a relevant life/natural sciences subject
• 5+ years of experience in Quality Assurance or Regulatory assurance in a Notified Body organization
• 2+ years of team management experience
• Completed Medical device training on MDD, MDR, IVDR, UKCA, MDSAP, and ISO 13485
• 10+ years of experience in a Health Science related industry or relevant regulatory functions