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Regulatory R&D Manager
- Posted 17 October 2022
- LocationGermany
- Job type Permanent
- Reference70211
- Contact NameJosh Greaves
Job description
Senior R&D Manager
Introduction
A highly successful, global In-Vitro Diagnostics (IVD) Manufacturer, headquartered in Frankfurt, Germany is searching for a talented and experience R&D Manager. You will be responsible for R&D of their Assays and Reagents as well as working closely with Regulatory Affairs related to submissions and Design Control processes.
This role will offer you
- The opportunity to join an established organisation with a broad product portfolio
- Opportunity to be hands on involved in R&D as well as leading a team
- Opportunity to report in to C-Level function
You will be responsible for
- R&D Strategy and Managerial Activities
- Review Project Deliverables & Ensure Timelines are Adhered to
- Research & Development of Reagents & Assays in Product Portfolio
- Ensure Regulatory Compliance Throughout R&D Process
You will bring the following
- 5+ Years’ Experience in a Medical Laboratory Environment
- Deep Understands of IVD Products (ISO13485, IVDD/IVDR, GMP, GLP)
- EU & FDA Regulatory Submissions Experience / Exposure
- Fluent German & English
- PhD or Masters Educated
BioTalent Ltd are acting as an employment agency in relation to this opportunity.