Clinical Affairs Manager

5 Mar 2024
Job Information

Organisation/Company

MRIguidance

Research Field

Technology
Medical sciences

Researcher Profile

Recognised Researcher (R2)

Country

Netherlands

Application Deadline

22 Mar 2024 - 22:59 (UTC)

Type of Contract

Temporary

Job Status

Not Applicable

Hours Per Week

40.0

Is the job funded through the EU Research Framework Programme?

Not funded by an EU programme

Is the Job related to staff position within a Research Infrastructure?

No

Offer Description

About MRIguidance

MRIguidance is a MedTech company that provides BoneMRI, a software solution (SaMD) developed through artificial intelligence and deep learning, that generates a 3D CT-like image to visualise bone structures derived from an MRI scan. This technology enables radiation-free bone imaging, improves diagnosis and is used for surgical planning and navigation. In July 2020, it was selected as Europe’s best-in-class innovation in healthcare by the European Institute of Innovation & Technology. BoneMRI is CE and FDA cleared.

Our values

As a growing company, your personal development is stimulated such that your skills and capabilities grow with the needs of the company. We believe in the strength of a collaborative and open minded team motivated to seamlessly shape the future of medical imaging. We are a community of reliable and competent professionals with the drive to always improve ourselves, our work and our product. Everyone is encouraged to bring out the best in others and do their best for others because we really do care!

What you tell at birthdays about your job

“The company I work for developed a software solution called BoneMRI that prevents the need of exposing patients to x-ray based CT scans with harmful radiation. BoneMRI is a radiation-free alternative that provides both bone and soft tissue information using only one machine and undergoing one exam, which reduces patients’ burden, and saves time and money for hospitals. My job is to validate our products by evaluating evidence that shows our product is safe and effective.”

What you actually will be doing

As part of the Clinical Team of MRIguidance, you will be involved in a wide range of projects and tasks that relate to the collection of clinical evidence by validating clinical data from clinical studies, writing reports and white papers and supporting clinical pilots. These are a crucial part of the CE and FDA certification, to validate the medical device for new purposes, applications, and patient populations and as well as the commercialization of BoneMRI. In addition, the Clinical Team collects feedback from potential end-users and performs market research to get a better understanding of the clinical workflows, patient journeys, product usage, clinical needs and the current market Together with other departments, you will use that feedback to steer development from a clinical perspective and support the commercialization of the product. Your tasks will be the planning, management and administration of these clinical projects, focusing on the different phases of the product life cycle by following the MDR and ISO 14155 as a guide. You will facilitate communication and interaction with clinical doctors, end-users and participating medical centres in Europe and the USA.

You will be part of the Clinical Team and report to the Head of Clinical Affairs.

Your responsibilities

• Project management;
• Clinical study management, including database management, writing and reviewing study documents, ethics and regulatory submissions.
• Define customers’ clinical and economic needs and the product value for our end-users;
• Gain a thorough understanding of the clinical workflow and patient journey for spine diagnosis, surgical planning and navigation;
• Maintain contact and relationship building with KOLs, doctors and researchers from medical centres and collect feedback from (potential) end-users;
• Support the stages of the product life cycle, including collecting and analysis of clinical evidence, identification of customers needs, positioning and commercialization of the product, and post-market surveillance;
• Understand the healthcare and competitive landscapes;
• Critically evaluate scientific literature and research findings on the clinical value and identify gaps in the clinical evidence of our product;
• Support generating educational material for customers;
• Identify, validate and write reports about the clinical evidence on the performance of our product;
• Support the commercialization by understanding the customer’s need, the value of the product and the market and translate these requirements into presentable materials.

Requirements
Specific Requirements

Qualifications

Minimum:

• Life Science or medical/technical MSc degree;
• At least 5 years of work experience of which at least 3 years of relevant experience within the life sciences or healthcare industry, preferably with medical technology;
• Strong communication skills;
• Strong in critical thinking and analytical skills;
• Academic and/or clinical writing skills;
• Fluency in English;
• Good knowledge of Microsoft Office tools;
• Team player;
• Proactive, open-minded, broad interest and eager to learn;
• Ability to communicate and collaborate effectively with researchers and clinical specialists.

Preferred:

• Knowledge of the MDR and ISO14155;
• Knowledge of the surgical orthopaedics field and radiology;
• Knowledge of health economics;
• Knowledge of the healthcare systems, market and clinical patient workflows;
• Fluency in Dutch;
• The desire to work in a dynamic environment of a young and fast-growing medical technology company.

Additional Information
Benefits

Our offer

• A full-time position
• A market conform salary between €4.250 and €4.750 per month
• Holiday (8%) and employers’ pension contribution (6%), plus optional bonus in shares/SAR after a year;
• A unique opportunity to become part of an early stage med-tech scale-up with vast growth potential;
• Work that has a positive impact on people’s health and life;
• A team of dedicated, smart and ambitious people;
• Work with leading international partners and key medical experts;
• Work in a highly skilled professional environment where you get both freedom and responsibility;
• Work at our beautiful office at the Maliesingel in Utrecht.

We believe diversity is beneficial for the creativity and a good atmosphere of our company. However, Dutch regulation makes it very complicated for small companies to process a work visa for people from outside the EU. Therefore, all people are welcome to apply, as long as we do not have to arrange a work visa.

Selection process

Interested or curious about the position?

To apply, please send a motivation letter and your CV by clicking the application button above.

Additional comments

Interested or curious about the position?

For more information about this position please contact Carrie Wismans by email: [email protected] .

To apply, please send a motivation letter and your CV by clicking the application button below.

Website for additional job details

https://www.academictransfer.com/338547/

Work Location(s)

Number of offers available

1

Company/Institute

MRIguidance

Country

Netherlands

City

Utrecht

Postal Code

3581 BG

Street

Maliesingel 23

Geofield

Where to apply

Website

https://www.academictransfer.com/en/338547/clinical-affairs-manager/apply/#apply

Contact

City

Utrecht

Website

http://www.mriguidance.com

Street

Gildstraat 91a

Postal Code

3572 EL

STATUS: EXPIRED