Senior Quality & Regulatory Affairs Manager

Introduction

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