Medical Device Consultant - 100% REMOTE

We 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.

This role is 95% Home Office with the exception of coming to the office in Freiburg for 2 or 3 days a month (all at the companies expense of course). Enjoy the freedom and flexibility of home office. This employer understands now-a-days there is a priority for having a work/life balance and that cutting out commuting can have exceptional benefits for you. Use your spare time for other aspects of your life, to ensure you're recharged and ready for the next day of work!

What we offer

• Diverse and International workforce
• Work from home
• Long term development opportunities
• Individually tailored on-boarding
• Flexible working time models - family friendly
• Attractive salary, pension scheme, capital forming benefits
• Company parties and events for you and the family

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