3 months ago
Hamlyn Williams has partnered with a new innovative start up Medical Technology company based in the Dortmund area that is in a Major phase of growth and therefore looking for a Quality Assurance/ Regulatory Affairs Manager.
The role will involve:
- For this position you will be responsble for the QMS in accordance with ISO13485 standards and therefore act as the responsible person according to MDR
- In regards to the QMS you will implement and maintain this system
- Lead both Internal and External audits and therefore be the contact person for Quality and Regulatory requirments
- Working in a stand alone posiiton where you will work collaborativley with product development and other departments.
For this role you will need:
- Experience in either the Medical Device or Medical technology space
- Experience with both Quality Assurance and Regulatory Affairs (However can be stronger on one sider)
- Fluent speaker in both German and English
- Be an independant person who is able to adapt quickly and likes the challenge of a start up company
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.