To our Lund and Stockholm offices we are looking for an experienced QA&RA professional in the Medical Device industry. As a senior consultant at QAdvis you are expected to support our national and international clients with highly qualified advice and hands-on work. QA&RA span over many areas and the candidate’s personality and competence will determine how it matches the company’s needs. Your basic education could be clinical, engineering, law, science or similar.
The work may involve Quality Management Systems, auditing, risk management expertise, process validation, SW validation, biocomp, clinical evaluation, clinical performance evaluation, development process, CE-marking process MDD/MDR/IVDD/IVDR, 510k process, PMA-process, UDI, compliance issues, warning letters, training sessions, national device registrations, European Authorized Representation, negotiations with national authorities.etc.
Following skills are desired:
Deep knowledge in the regulatory framework of medical devices and/or in-vitro diagnostic devices.
Experience from providing regulatory strategies for medical devices and IVD devices in EU, USA and other countries.
Good understanding of clinical evidence requirements.
Practical experience from working with different risk classes of medical devices and IVD devices.
Excellent skills in Swedish and English are mandatory, other languages are appreciated.
The consultant work is performed both from the office and at client sites. Our customers span from startups to large international companies. Most customers are located in Scandinavia but we have also customers in EU, USA and Asia.
To be on top of the subjects, the job includes to arrange for your own 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 to provide customers with appropriate professional support. Integrity, a desire to deliver excellent results, a sense for business, self-going, highly communicative at the right times are all important capabilities.
We offer salary and compensation according to a scheme with large individual flexibility.