about 2 months ago
Hamlyn Williams has partnered with a major player within the Medical device space. This company is a global leader in its field and therefore due to expansion is looking for a Regulatory Affairs Manager that can be 100% remote based with occasional travel to site.
The role will involve:
- You will manage international product approvals. This will include necessary reporting to authorities according to MDR 2017/745 for class III products
- Regulatory compliance and maintenance of international products including existing registrations/CE certifications and product technical documentation
- Involvement in Notified Body audits
- Work with other departments on a global scale
For this role you will need:
- Experience in either the Medical Device or Medical technology space
- Experience within Regulatory affairs specifically with international product registrations
- Experience with Class II-III products
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.