Head of Quality & Regulatory Affairs

Introduction

This role will offer you

• The opportunity to join a mid-size organisation, and one of most successful in it’s field
• Opportunity for growth in your career with role progression and education
• Opportunity to work in a flat hierarchy

You will be responsible for

• Strategic Decisions in Quality Management & Regulatory Affairs (ISO13485, MDR)
• Global Product Submissions (EU-MDR, FDA & Others)
• Management of Managers (Currently 3)
• Notified Body Point of Contact (DEKRA)

You will bring the following

• Extensive Background in Quality & Regulatory Affairs in the Medical Device Space (ISO13485, MDR)
• FDA & CE Mark Regulatory Submissions Experience
• PRRC Qualified
• Line Management Experience
• Fluent English & Minimum B2 German