QA/RA Specialist

Position Summary
Job Title: QA/RA Specialist
Location: Vienna, Austria

Key Responsibilities
 Support and maintain the Quality Management System compliant with ISO 13485
 Prepare and maintain technical documentation in accordance with EU MDR (2017/745)
 Support regulatory strategy for CE Marking
 Assist in regulatory submissions including FDA 510(k) planning/documentation
 Manage Design Control documentation
 Perform risk management activities (ISO 14971 knowledge desirable)
 Coordinate CAPA, Change Control, Non-Conformance and Internal Audits
 Support supplier quality activities
 Work closely with R&D, Engineering and external regulatory consultants during product development
 Support documentation for animal studies and subsequent clinical investigations

Required Skills
Must Have
 Experience in Quality Assurance and Regulatory Affairs within Medical Devices
 Strong knowledge of EU MDR
 Working knowledge of FDA 510(k) pathway
 Experience with ISO 13485
 Technical documentation preparation
 Excellent documentation and communication skills

Preferred
 Degree in Biomedical Engineering (preferred)
 Life Sciences or related engineering disciplines also considered

 Experience supporting Class II/III medical devices
 Knowledge of ISO 14971
 Experience in startups or product development environments
 

Ideal Candidate
The ideal candidate is someone who enjoys building systems rather than maintaining mature processes. Since this company is still in the early development phase, they need someone who can work hands-on with founders and engineers, establish compliant documentation, and help navigate the transition from prototype to clinical validation.

The strongest candidates will typically have:
 3–8 years of QA/RA experience,
 hands-on involvement with EU MDR technical files,
 experience preparing for Notified Body audits,
 and some exposure to FDA 510(k) submissions.