Quality & Regulatory Manager

Posted 12 October 2022
Job type Permanent
Contact NameJosh Greaves

Job description

Senior Quality & Regulatory Affairs Manager


A well established, newly acquired Medical Device manufacturer in the field of Cardiovascular Diagnostics is currently searching for an experienced Quality & Regulatory Manager on a permanent basis. This is a role that offers hybrid working flexibility but will require you to be located in or close to Berlin, Germany.

This role will offer you

  • The opportunity to join a start-up environment, now heavily invested in by it’s new owners
  • Opportunity to grow with a company that aims to grow by 100% in both revenue and headcount in the next 12 months
  • Opportunity to report in to C-Level function

You will be responsible for

  • QMS & Regulatory Strategy on a Global Level
  • Internal & External Auditing & Auditing of Suppliers (ISO13485, 9001)
  • Global Product Submissions (EU-CE Mark, FDA 510(k) & others)
  • Training & Mentoring of New Employees

You will bring the following

  • Extensive Experience in Quality Management Systems Implementation (ISO13485)
  • Ideally eQMS Experience
  • Experience in Medical Device Submissions on a Global Level
  • Deep Understanding of Appropriate Standards (ISO13485, IEC 60601-1, IEC 62304, IEC 62366, EU MDR)
  • Fluent English


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