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 Quality Assurance/Regulatory Affairs Manager that can be 100% remote based with occasional travel to site.
The role will involve:
- You will also act as the Person resposible for Regulatory Complience where you will take ownership of the regulatory technical documentation.
- You will be the main person for communication and allignmend with regulatory authories
- Main person responsible for the development of the Quality Management System. You will be responsbile for getting it certified according to ISO 13485
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
- Hands on experience with the QMS and expereince with the ISO13485:2016, IEC 62304:2006, and ISO 14971 standards
- 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.