Site Auditor for RISE Medical Notified Body AB - Hiring in process/Finished, not possible to apply

Are you interested in contributing your knowledge and experience to ensure the safety and performance of medical devices? Then you may be the person we are looking for!

RISE Medical Notified Body AB (MNB) is a newly started, independent RISE subsidiary aimed to become a notified body for medical devices. The company is currently undergoing the process of being approved as a notified body and the business is expected to have strong growth in the coming years.

In order for a medical device manufacturer to place its product on the European market, the device must comply with the applicable medical device regulatory requirements (MDR). When the device is deemed to meet the essential requirements of all relevant European directives/regulations for medical devices in force, the device may be CE-marked and placed on the European market.

RISE Medical Notified Body AB is now looking for someone with medtech experience to audit manufacturers according to the new medical device regulations (MDR).

About the role
As the Site Auditor, you will perform audits of manufacturers’ quality management systems and, when needed, those of their suppliers and/or sub-suppliers. The role also includes reporting on conducted audits. This position entails travel, primarily in the Nordic region.

The location of the position is flexible.

Who we are looking for
We are looking for candidates with a degree from university, college, technical college or equivalent qualification in relevant sciences, such as medicine, pharmaceuticals, engineering, biology, microbiology, chemistry, materials science, veterinary medicine, physiology, toxicology or physics.

You must have occupational experience of medical devices or related activities, as well as quality management experience. We are seeking those with previous experience of the product group or technology to be audited and those who have knowledge and experience of risk management, associated product standards and guidance documents.

Furthermore, you have knowledge of device legislation, related harmonised standards, common specifications and guidance documents, as well as of quality management systems and related standards and guidance documents. You have experience in drawing up protocols and reports showing that relevant conformity assessments have been appropriately carried out. You are proficient in spoken and written Swedish and English.

In order to be successful in the role of Site Auditor with us, we believe that you are an independent person who also has the ability to work in teams, you are organised and analytical, have an eye for detail and, not least, we believe that you are focused on delivering accurate analyses and documentation within the set timeframes.

Are we a good match?
As an MNB employee, you will have the opportunity to make an impact and to develop in a brand-new company driven by competence, commitment and a common desire to ensure that safe medical devices reach patients and users. Interested in joining us on our journey?

Would you like to learn more?
For questions about the position, please contact recruiting manager Tomas Holm, +46 10 516 59 88, available 9-13 August or contact person Sara Bergh, +46 10 516 69 44 available 5-9 July and 2-6 August, 9 am-12 pm.

Our union representatives are: Lazaros Tsantaridis, SACO, +46 10-516 62 21 and Linda Ikatti, Unionen, +46 10-516 51 61.

For this position you will be employed by RISE Medical Notified Body AB. RISE Medical Notified Body AB is thus the data controller in the recruitment and upcoming employment. Read more about how we process your personal data in connection with recruitment: https://www.ri.se/en/about-rise/policy-documents/personal-data-processing/recruitment