Senior Quality & Regulatory consultant
To our Lund or Stockholm office we are looking for a Senior Quality & Regulatory consultant in the Medical Device and In Vitro Diagnostic 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 highly 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, development process, CE-marking process under MDR and IVDR, technical documentation, 510k and PMA application, UDI, compliance issues, warning letters, training sessions, national device registrations, European Authorized Representation, negotiations with national authorities and notified bodies, etc.
Following skills are mandatory:
- Deep 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.
- Leadership skills and interest in leading mid-size projects; internally or leading assignments from our customers.
- Excellent skills in Swedish and English are mandatory, other languages are appreciated.
Other skills such as good understanding of clinical evidence requirements, biocompatibility, 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 possible 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 stay up to date on relevant 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, often as a team. Integrity, a desire to deliver excellent results and lead others, a sense for business, self-going, and high communication skills are all additional important capabilities.
We believe that you have 5-8 years of experience in relevant roles within the medical device industry.
We offer salary and compensation according to a scheme with large individual flexibility.