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

Have you considered how medical devices in your clinical everyday life are quality assured before they are allowed to be used on patients? Are you interested in contributing your knowledge and experience to ensure the safety and performance of medical products? 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 clinical experience to assess devices according to the new medical device regulations (MDR).

About the role
As a Clinical Specialist, you will be part of an evaluation team responsible for monitoring clinical assessments of technical documentation in line with internal procedures for assessment and decision-making. The role includes responsibility for reviewing and scientifically questioning clinical data in the clinical evaluation, and all associated clinical trials.

The position may also include final review of other clinical assessments and educating others within the organisation in product knowledge and risks for clinical use.

The location of the position is flexible.

Who we are looking for

We are looking for those with work experience following a medical degree, dental degree or as a specialist nurse with at least 2 years of clinical experience in areas covering evaluated and approved product codes. You are proficient both in spoken and written Swedish and English.

You have knowledge of the basic principles for assessing clinical data, for medical equipment and medical statistics; and direct work experience in patient care and/or clinical research or related experience, in particular in conducting or assessing preclinical or clinical trials or clinical data.

We are looking for those with good knowledge of the products to be assessed. You have the ability to draw up protocols and reports that show that relevant conformity assessments have been appropriately carried out.

In order to be successful in the role of Clinical Specialist 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. The deadline for applications is 15 August 2021.  

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