Quality & Regulatory consultant MedTech, system developer

To our Stockholm office we are looking for System developer consultant with focus on Quality & Regulatory (QA&RA) in the Medical Device industry.
As a consultant at QAdvis you are expected to support our national and international clients with qualified advice and hands-on work, if needed supported by our more experienced colleagues. QA&RA span over many areas and the candidate’s personality and competence will determine how it matches our company’s needs.
The work will involve Quality Management Systems, system development, risk management, process validation, SW validation, development process, verification and validation, CE-marking process MDD/MDR/IVDD/IVDR, technical documentation, etc.
Following skills are desired or mandatory:
· Higher education in engineering is mandatory, for example MSc.
· Experience from working with quality management system development, customization, and implementation according to ISO 13485 for medical device manufacturers is mandatory.
· Experience from working with medical device software, IEC 62304, IEC 60601-1 and CFR part 11 is mandatory.
· Experience from software design and development, requirements, Java, risk management and verification and validation is mandatory.
· Knowledge in the regulatory framework of medical devices (MDR) and/or in-vitro diagnostic devices (IVDR) is mandatory.
· Basic skills in Swedish are mandatory.
· Excellent skills in English are mandatory, other languages are appreciated.
Our work is performed both from our offices and at client sites. We work individually or in teams to support the customer in the best way and also to learn from each other. Our customers span from start-ups to large international companies. Most customers are in Scandinavia, but we also have customers in EU, USA, and Asia.
To be on top of the subjects, the job includes continuous education by for example participating in IEC/ISO standard committees, EU-working groups, attending conferences, speaking at seminars/trainings, etc.
Travel to a certain degree will be necessary, but not exaggerated to keep a good balance with your private life.
We highly value social competence to properly read the situation and the customer expectations, and to provide our customers with professional support. Integrity, a desire to deliver excellent results, a sense for business, self-going, high communication skills are all important capabilities.
2-4 years of experience of QA&RA roles in the medical device industry and 8-10 years in the software industry is required.