Vacancy Regulatory Affairs Specialist – Karise


Organization

One of the smaller yet rapidly growing Medical Devices companies is currently looking for a Regulatory Affairs Specialist who has experience with Medical Devices. The company has a good reputation on the market and is known for its ability to support the growth of its employees. In addition, they have a great professional atmosphere that is open and down to earth.

Function

Your major tasks will be to make sure that all regulatory documentation applies to the current legislation in the EU regarding Medical Devices. You will also be collecting and developing the necessary documentation while also being proactive and curious regarding possible updates or alterations in the current legislation which you will be relaying directly to the VP of quality and regulatory affairs. Lastly, this position also has an element of development since you will also become a part of the development team supporting them in a variety of tasks.

Requirements

The ideals candidate profile looks the following:

  • You hold a master’s in a relevant field e.g. Mechanical Engineering, Chemistry, or Biology
  • Have at least four years of experience with medical devices from a Regulatory Affairs perspective and Documented experience with requirements from MDR, ISO 13485 and 14971, MEDDEV, GHTF, IMRF, and FDA
  • Are proactive and curious
  • A team player who is detail orientated and a strong communicator
  • Fluent in English on a professional level
  • Fluent in Danish is considered a plus

Offer

The organisation can offer:

  • Good opportunity for internal growth
  • Competitive salary
  • Forthcoming colleagues
  • A professional atmosphere with a focus on personal and professional development

Application

Does this job sound like you, or could you be interested in similar jobs, or just jobs within the Life Science sector? do not hesitate to contact me directly.


Nicklas Smed Poulsen

Associate Recruiter | Nordics


+45 89 88 26 70

n.poulsen@qtcrecruitment.com