Regulatory Affairs Manager

Posted 05 October 2022
Job type Permanent
Contact NameJosh Greaves

Job description

Senior Regulatory Affairs Manager


A highly innovative, specialist Dental manufacturer located in Berlin is searching for a talented Senior RA Manager to spearhead their Regulatory operation and to take responsibility over their global submissions process.

This role will offer you

  • The opportunity to join a start-up environment, now heavily invested in by it’s parent company
  • Opportunity for growth in your career with role progression and education
  • Opportunity to report in to C-Level function

You will be responsible for

  • Global Regulatory Strategy
  • Global Product Submissions (EU-MDR, FDA, Japan, Brazil & Others)
  • Quality Management Systems (GIT) Implementation According to ISO13485
  • Training & Mentoring of New Employees

You will bring the following

  • 5+ Years’ Experience in Regulatory Affairs in the Medical Device Space
  • EU-MDR & FDA Submissions Experience
  • Quality Management Systems Implementation Experience
  • Ideally Knowledge of SaaS & SaMD Requirements
  • Fluent English


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