To our Lund office we are looking for Quality & Regulatory (QA&RA) consultants 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. Your basic education could be clinical, engineering, law, science or similar.
The work may involve Quality Management Systems, auditing, risk management, process validation, SW validation, biocompatibility, clinical evaluation, performance evaluation, development process, CE-marking process MDD/MDR/IVDD/IVDR, technical documentation, 510k and PMA application, UDI, compliance issues, warning letters, training sessions, national device registrations, European Authorized Representation, negotiations with national authorities, etc.
Following skills are desired or mandatory:
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.
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.
We believe that you have 5-8 years of experience of relevant roles in the medical device industry.
We offer salary and compensation according to a scheme with large individual flexibility.