Job Title: Quality and Regulatory Affairs Manager (Medical Devices)
Location: Aachen, North Rhine-Westphalia, Germany
Working with a dynamic, fast-growing start up based in Germany, focused on developing innovative technological solutions for critically ill patients, and they are looking to hire a Quality and Regulatory Affairs manager. This is great chance to develop and better your skills within the field, with a company that has massive potential in the future
Candidates will need:
· Completed technical or scientific degree or a similar qualification,
· As well as two years of professional experience within a similar position.
· In-depth knowledge of the usual approval requirements and standards of medical technology, (e.g., B. ISO 13485, ISO 14971, 21 CFR part 820, MPG, MDR).
· Superior communication skills and experience working in different teams and project development.
· Great writing, presentation, and communication skills in English.
· Project management skills.
Bonus points, if:
· Experienced within project management.
· You have a background in computer science.
- Understanding of regulatory and normative requirements enabling approval of the products
- Usage of continuous improvement to promote quality culture
- Helping with technical documents for all products- in compliance with laws and regulations
- Supporting with audits both internally and externally
- Complaint monitoring and using the correct preventative structure
- Supplier evaluation- preparation of data and key figures for review
What they offer
· Competitive salary, commensurate with experience.
· Aiding personal development and reaching your career goals
· Positive working environment.
· Some flexibility with remote based work