Clinical Affairs Specialist

The Clinical Affairs team

You will be part of a small and friendly team with a focus on collaboration and team spirit. The Clinical Affairs team at CellaVision is responsible for assuring that the products we place on the market have undergone sufficient Clinical Performance Studies. The team plans, executes and reports to the Clinical Performance Studies.



About the position

As a Clinical Affairs Specialist, your main responsibility will be to plan and execute performance evaluations, as well as the pre-and post-market studies. The Clinical Performance Studies generate large amounts of complex data which you will analyze and draw conclusions from. You will also be an active part in interacting with internal experts and various laboratories in product development projects. The organizational place for this position is in the Quality department and you will report to the Clinical Affairs Manager.

Key tasks as a Clinical Affairs Specialist

- Be part of creating and maintaining Performance Evaluations Reports for all of CellaVision's products.

- Plan and design Clinical Performance Study Protocols (CPSP) together with the Clinical Affairs team.

- Plan, initiate, and coordinate Clinical Performance Studies together with the Clinical Affairs team.

- Ensure that the Clinical Performance Studies are in compliance with all applicable regulations and company procedures.

- Process data from Clinical Performance Studies, including but not limited to analysis, interpretation, and compiling of reports.

- Contribute to and review submissions to authorities.

- Take part in pre-submission meetings with FDA regarding CPSP design.

- Interact with all departments at CellaVision as well as directly interact with investigators.



What can we offer you?

You will be a key part of the Quality organization and will be working in close collaboration with both internal and external interested parties. CellaVision has a world-leading position in digital cell morphology, and we see our employees as our primary resource for our ongoing innovation and success. This is an excellent opportunity for you who want to participate in the development of medical devices where quality, innovation, and GCP/GLP are constantly in focus. Other great things with working at CellaVision are:

- We have a friendly and open company culture and a flat organization.

- We have flexible hours to promote a work-life balance.
- We have collective agreements, ITP-pension, parental leave supplement, reduction of work hours.




Qualifications

- Bachelor or Master’s degree within life science area

- Minimum 3 years of experience in clinical studies related to medical devices, preferably IVD, or experience of working in a controlled laboratory environment.

- Understanding of legal and regulatory requirements (e.g., GCP, ISO standards, and IVDR/MDR guidelines).

- A well-developed communicative ability, speaking and writing in English.



Meritorious

- PhD within related field.

- Good knowledge of statistics.

- Good knowledge of ISO 14115, or ISO 20916.

- Knowledge of QSR (21CFR820) or other regulatory requirements within the medical device field.

Who you are

We believe you have strong analytical skills as well as an eye for detail when it comes to analyzing data and drawing conclusions from it. Since we are a medical device company and often have strict deadlines, you need to be structured and plan, organize and prioritize your work effectively. We believe that you are self-driven, take initiative, and take responsibility for your work. Finally, since you will work in a small team as well as have a broad network internally and externally, we believe you find it easy to cooperate and thrive in a social context.



Care to join?

This is a full-time position based at CellaVision HQ in Lund, Sweden. Note that this position may require approximately 20 to 30 traveling days yearly.

Submit your application including your CV and attachment letter. We will work with continuous selection and interviews, so please send your application as soon as possible but no later than November 29, 2021.

To know more about the position, please contact recruiting manager Karin Hannander, Clinical Affairs Manager, at karin.hannander@cellavision.se. Questions about the recruitment process contact Caroline Herrlander, HR Specialist, at caroline.herrlander@cellavision.se.

Note that you need a valid working permit in Sweden.

We decline all contact regarding services in advertising, consulting, or recruitment