4 months ago
Hamlyn Williams has partnered with a Medical Technology company based in Bavaria that is in a Major phase of growth and looking for a Regulatory Affairs Manager.
The role will involve:
- Managinging this companies certification or registration in order to achieve all certification/registrations
- Maintain regulatory files
- Responsible for CE technical files and notified body audits
- Responsible for US submissions and direct interactions with FDA.
- Develop and implement complex regulatory project plans
- Manage regulatory activities relating to specific portfolio of products/projects
As a Regulatory Affairs manager you will need:
- Experience in Regulatory Affairs
- Medical device background.Specific medical technology experience would be advantegous
- Knowledge of international and European MDR and international/European standards
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.