about 2 months ago
Hamlyn Williams has partnered with a rapidly expanding Medical technology company specifically within the digital health space based in Germany. Due to expansion this company is looking for a Regulatory Affairs Manager that can be 100% remote based with occasional travel to site.
The role will involve:
- Through cross collaboration implement strategies to enable the product to be and stay successfully approved by the BfArM on the German market
- Actively work on documentation on the Quality Management System
- Act as the PRRC
- Compile and ensure completeness of the technical file
- Ensure processes to comply with Post-Market Surveillance requirements
- Establish project and process metrics to measure the success and progress of the strategy implementation.
For this role you will need:
- Experience in either the Medical Device or Medical technology space (This is a saMD product so experience within this area is advantegous)
- Experience within Regulatory affairs and Quality assurance
- Be able to work independantly
- Fluent English speaking, German is advantegous
I am a Quality Assurance and Regulatory Affairs market specialist working with a large variety of clients across the Medical Device industries. If this role is of interest to you, or if you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Leah at +44 020 3545 1118 or at firstname.lastname@example.org.