Vacant job

Do you want to help ensure the safety of medical devices? Then this could be the job for you! We are looking for new colleagues who want to be part of a newly established company for the certification of medical devices. Now is the opportunity to develop and grow in a startup with high ambitions to expand!

About us

RISE Medical Notified Body AB (RISE MNB) is a subsidiary of RISE AB with the mission to review and assess that medical device manufacturers and products meet the requirements of the new EU Medical Device Regulation 2017/745, MDR. At the beginning of 2024, the company was approved as a notified body for medical devices, and the business is expected to experience strong growth in the coming years. As a notified body, RISE MNB is an incredibly important and critical part of the quality process, as many medical devices must be reviewed and assessed by a notified body to be placed on the market and thus made available to healthcare.

We offer a secure workplace with collective agreements, and we place great emphasis on creating a positive work environment and satisfied employees. With us, you also have the opportunity for flexible working hours.About the role

As a project manager at RISE MNB, you will play a central role in leading and coordinating certification assignments for manufacturers of medical devices. You will be responsible for guiding clients through the entire process from inquiry to certification and be the primary point of contact for our clients. In the role of project manager, you will work closely with a technical specialist and a planning coordinator.

Your main responsibilities:

• Create, nurture, and maintain customer relationships,
• Work as a project manager according to the definition in Annex VII section 4.4 of the MDR,
• Manage assignments within the scope of RISE MNB and ensure delivery according to the highest quality standards with a strong customer focus,
• Conduct and document assessments of inquiries and applications,
• Prepare quotes and contracts with our clients, as well as assist with invoicing,
• Ensure that the right competencies are allocated to each assignment,
• Coordinate with the EU Commission and follow up on feedback from the expert panel,
• Create documentation for certificates and decision letters,
• Contribute improvement suggestions to RISE MNB's processes and routines,
• Ensure independence, confidentiality, and impartiality from commercial and other interests.

Does remote collaboration work?

Yes, we believe it does! Our clients are geographically dispersed, and so are we. To provide our employees with the best conditions to combine private life with the next step in their career, we offer flexible hybrid work. Our headquarters is located in Kista, but you have the option to choose the location for the role.

Who are you?

To succeed in the role of project manager, you have the following qualifications and experiences:

• A degree from a university or college or equivalent qualifications in relevant subjects, e.g., engineering, medicine, or other relevant sciences.
• At least two years of experience working with medical devices and thus knowledge of MDR (MDD) and ISO 13485.
• At least two years of experience working as a project manager.
• Knowledge of medical technology, its regulations, and standards.
• Good ability to express yourself well in speech and writing, in both Swedish and English.
• Familiarity with working at a certification body or notified body is an advantage.

You are used to working independently as well as in project teams. Furthermore, we believe you are organized and analytical with an eye for detail. Important in the role of project manager is that you have a strong customer focus and want to create value by building long-term relationships. Additionally, you are focused on delivering accurate analysis and documentation within established timelines. Are we right for each other?

As an employee at RISE MNB, you will have the opportunity to influence and develop in a new company under development driven by competence, commitment, and a shared desire to ensure that medical devices reach patients and users. Our culture is characterized by joy at work and collaboration with fantastic colleagues - Do you want to be part of our team?

Welcome with your application!

In this recruitment process, selection is ongoing, with immediate start or by agreement. If you have questions, please contact Jörn David, RISEMNB,+46 73 042 03 47. The recruiting manager is Åsa Betten. The last application date is January 26, 2025. Our union representatives are: Linda Ikatti, Unionen, 010 516 51 61, and Ingemar Petermann, SACO, 010-2284122. The RISE group has a collective agreement according to the Technical Services Agreement. 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.