Medical Affairs Specialist

MagVenture A/S is expanding and therefore, we are seeking to recruit a colleague for a new position as Medical Affairs Specialist as part of our Medical Affairs team in our HQ in Farum, Denmark. The ideal candidate will help to ensure the company’s continued international success and maintain our position in current markets. Your primary focus will be on driving and maintaining MagVenture’s Clinical Evaluation Reports and Post Market Surveillance reporting. The position is intended as full-time but part-time can be discussed.

You will be part of a small, dedicated team consisting of 2 medical affairs colleagues, 4 regulatory affairs specialists and 2 applications specialists. We are a dynamic company with a strong team culture. The atmosphere is informal and welcoming, with a flat organizational structure that keeps decision-making close at hand.

Tasks:

• Drive and maintain Clinical Evaluation Reports (CERs) on our existing portfolio to meet the requirements of the Medical Device Regulation (MDR).
• Develop, plan, and write CERs for potentially new indications for uses and/or new products.
• Handle and evaluate Post-Market Information data on an ongoing basis.
• Write and update Periodic Summary Update Reports (PSUR).
• Provide input and support to development projects as well as other regulatory documents, like ‘Instructions For Uses’, usability reports, clinical risk documentation, etc.

Applicant Profile
We expect that you have:

• A Master of Science degree, maybe complemented with a PhD or other types of research/clinical experience.
• Previous experience as a medical/scientific writer of clinical, regulatory documents, primarily Clinical Evaluation Reports (CER).
• Knowledge of MDR, ISO-14155, ISO-13485 etc. and regulations of devices in Class IIa.
• A critical, scientific mindset with a thorough understanding of research methodology, including statistical methods, study design and research concepts.
• Strong analytical skills and the ability to communicate results clearly.
• Excellent written and verbal communication skills in both Danish and English.

On a personal level, you are structured, result-oriented, committed and can handle changes in prioritization of tasks. You thrive in a small business where you need to follow projects from one end to the other and contribute to an open and dynamic collaboration with your colleagues, from many different functional areas.

We offer:

• The possibility to help establish the backbone of new therapeutic approvals.
• An exciting position with a great deal of responsibility to influence decisions.
• Good possibilities for continuing professional development and education.
• Flexibility in planning your tasks and work.
• An easy-going and collaborative work environment.
• Flex time, pension, canteen, and health insurance.
• A newly built, super nice office in Farum.
• Start date: As soon as possible.

We are hoping to find the right candidate and we will call for interviews on an ongoing basis, so you are encouraged to submit your application as soon as possible.

We look forward to receiving your motivated application and CV.

About MagVenture
MagVenture is a Danish, family-owned company with headquarters and production in Farum. We currently employ ~200 people globally. MagVenture is the sister company of Tonica Elektronik that was founded in 1991, and has, since then, grown organically from a location in a small basement to becoming a global market-leading manufacturer of magnetic stimulators. Our products are used for a wide range of psychiatric and cognitive research purposes as well as neurorehabilitation, neurology & diagnostic. Read more about MagVenture on our website www.magventure.com.

Job location:
Farum

Application deadline:
Ongoing

If you have any questions, please contact

Kirstine Klitgaard Schou
Senior Medical Affairs Specialist

[email protected]

61 14 66 75