Careers / Open positions

Senior Quality & Regulatory consultant

To our Lund office we are looking for a senior Quality & Regulatory (QA&RA) consultant 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 other 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, form regulatory strategies, process validation, SW validation, biological evaluation, clinical evaluation, performance evaluation, interim management, development process, CE-marking process AIMD/MDD/MDR/IVDD/IVDR, technical documentation, 510k and PMA application, UDI, compliance issues, warning letters, training sessions, national registrations, European Authorized Representation, negotiations with national authorities, etc.

Following skills are mandatory:

  • Leadership skills and interested in leading/managing mid-size projects, internally or leading assignments from our customers.
  • Knowledge in the regulatory framework and quality management system of medical devices and/or in-vitro diagnostic devices,
  • Experience from providing regulatory strategies for medical devices or IVD devices in EU, USA, and other countries.
  • Practical experience from working with different risk classes of medical devices and IVD devices.
  • Excellent skills in Swedish and English, other languages are appreciated.

Other skills such as good understanding of clinical evidence requirements, biocompatibility, medical device software, electrical safety, etc. are advantageous.  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 clients range from start-ups to large international companies. Most clients are in Scandinavia, but we also have clients 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, webinars 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 client’s expectations, and to provide our clients with professional support. Integrity, a desire to deliver excellent results and lead others, 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.

Read more about us here (in Swedish)

Contact: Nils-Åke Lindberg or Emma Axelsson
Email your interest to jobs(at)qadvis.com or call us at +46 46 286 88 90