Certification Director 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. We are now looking for a candidate with medical experience of reviewing products according to the new medical device regulations (MDR), and for heading up the Certification unit.

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. MNB 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.

About the role
As Certification Director, you will be part of a team that conducts the final review of completed medical device assessments and participate in certification decisions.

The position also includes managerial duties.

As head of this unit, it is important that you have a coaching leadership style and are passionate about creating good conditions for your employees. You will enable a culture where everyone can do their very best. You are collaborative, trusting, courageous and results-oriented.

This role reports to the CEO. 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 have experience in conformity assessments under Directive MDD 93/42/EEC or regulation MDR 2017/745 and work experience relating to medical devices in a notified body, preferably as an auditor and/or product reviewer. You have good knowledge of the regulatory framework for medical devices and relevant guidance documents and qualifications, experience and expertise relevant to the assessment of device conformity.

You have good knowledge of technology regarding the devices checked for certification, the medical device industry and the development, design and manufacture of medical devices. You also have good knowledge of management systems, processes and necessary qualifications of relevant staff. The position requires that you have a good ability to express yourself well in speech and writing in Swedish and English.

To be successful in the role, we believe that you are a natural leader and role model who helps your employees perform to the best of their abilities. You are responsive and listen effectively, you are driven to deliver and you engage your employees through inspiring and courageous leadership. You involve and coach your employees in their commission of creating value and clear results.

We believe that you have good business acumen and inspire confidence in both customers and employees. It is very important that you are a team player with a pronounced ability to collaborate.

Are we a good match?
As MNB Director, 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?

We welcome your application
For questions about the position, please contact recruiting manager Tomas Holm, +46 10 516 59 88, available 28 June to 2 July, or contact person Sara Bergh, +46 10 516 69 44 available 5 July to 9 July and 2 August to 6 August, 9 am-12 pm. The deadline for applications is 8 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. MNB 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