Head of Quality 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.

We are now looking for a Head of Quality for RISE Medical Notified Body AB.

About the role
As Head of Quality, you will lead the organisation’s quality efforts. Your tasks include, e.g.:

• Maintaining and developing the management system and processes for fulfilling business requirements and informing internally.
• You will be the contact toward the Swedish Medical Products Agency and coordinate external audits/assessments/inspections.
• The role also includes evaluating incident and vigilance cases reported in from manufacturers or authorities.

The location of the position is flexible.

Who we are looking for
We are seeking applicants with a university degree or equivalent qualifications in relevant subjects, such as medicine, pharmaceuticals, engineering or other relevant sciences. You have solid experience of quality work pertaining to medical devices, knowledge of ISO 13485 and experience of working in a quality management system.

You have good knowledge of the regulations governing medical devices and relevant guidance documents, conformity assessment and experience in the development and manufacture of products, as well as knowledge of impartiality and independence.

A requirement of the position is that you have a good ability to express yourself well in speech and writing, in Swedish and English.

Are we a good match?
As a RISE MNB employee, you will have the opportunity to influence 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 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