Head of Quality & Regulatory

Posted 23 November 2022
Job type Permanent
Contact NameJosh Greaves

Job description

Head of Quality & Regulatory Affairs



A global Medical Device leader in the field of Oncology products, headquartered in Berlin is actively seeking a talented and seasoned leader in the field of Quality Assurance, Quality Management & Regulatory Affairs.

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

BioTalent Ltd are acting as an employment agency in relation to this opportunity.