AdresseWe are currently hiring various experience levels for a Regulatory Service Provider who has been active for almost 30 years. They support clients across the globe in in various sectors from pharmaceuticals, medical devices, in-vitro diagnostics and more! Take the next step in your career and become a consultant, working on multiple projects with various clients, using the expert level knowledge you have amassed during your career. By working with this company, you will be able to develop even further by having a worldwide reach within the Regulatory Affairs market, and really stand out.
We are looking for an Electrical Engineer who has transitioned into Regulatory Affairs, to avail of career progression where they can use the expertise they've compiled within the Medical Device industry to advise clients on how to achieve CE-Marking.
The role:
- Compile Technical Documentation
- Ensure that EU requirements are fulfilled such as 93/42/EEC, 98/79EC as well as any new EU regulations
- Collaborative work with in-house subject matter experts in relation to CE-Marking of Medical Devices/ In-Vitro Diagnostics
- Implement and maintain regulatory SOPs in line with ISO 13485
- Interact with clients, Notified Bodies and Competent Authorities
- Use analytical thinking to approach each situation is a customer orientated way
Your profile:
- Education in Engineering, preferably Electrical Engineering
- Strong knowledge of electrical safety topics
- Knowledge of IEC 60601-1 / 60601-X standards
- Project management skills
- Fluent German
- Fluent English
Added traits we'd love to see:
- Experience in CE-marking for software
- Experience with working with FDA submissions
- Knowledge of other standards like IEC 62304 and ISO 14971
- Medical Device or IVD industry experience, such as quality management or regulatory affairs
- Notified Body experience
