Senior Regulatory Affairs Manager

Introduction

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.