Smørum

Regulatory Affairs Manager

Fakta

Lokation:
Smørum
Ansøgningsfrist:
30/06/2019
Afdeling:
Quality
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Regulatory Affairs Manager

If we stated that you now had a chance to work to significantly chance peoples hearing experience worldwide by utilizing your skills within regulatory processes. Would you then dare to take it?

 

Could we allure you to join our specialized Regulatory Affairs team in one of the global leaders within hearing solutions? Then keep reading!

 

The setting you are getting into?

Our RA department consists of 16 highly dedicated people and is part of the QA & RA department. As a department we are responsible for the regulatory strategies for R&D project throughout the product development process. We manage regulatory strategies, risk management file, device and facility registrations, radio approvals, electrical safety approvals as well as standard and regulation requirements. Furthermore, we are involved in internal audit and system compliance according to EN ISO 13485 and FDA 21 CFR 820. We are also continuously involved in improvement projects.

 

The Challenge

You dare to make a difference and together with ambitious and talented colleagues, you will be part of a dynamic department.

 

You primary and secondary tasks would be to:

  • Take lead on updating the product Medical Device Files to be in compliance with the new EU Medical Device Regulation.
  • Take lead on regulatory aspects in R&D projects
  • Provide Regulatory Affairs Project Support, which includes managing and documenting the regulatory project strategy, classification and intended use, risk management file, standard requirements, technical file and review of marketing material.
  • Handle Regulatory Affairs tasks, which may include involvement in device and facility registrations, post market activities related to Risk Management File and Project Management within the Regulatory Affairs professional area.

 

You will be referring to the Director of Regulatory Affairs.

 

An engaging environment

We believe that the best results come from a fruitful team effort. We support each other and constantly share feedback and knowledge to improve our results. We have an informal and creative atmosphere where respect is pivotal and we strive for the common goal.

 

Furthermore, we trust and value your professionalism, experience and dedication. Your new perspectives, insights and ideas are the cornerstones of our success, and we encourage you to think out of the box and structure your workflow with a high level of freedom. You are shown professional respect making it challenging and meaningful to go to work every day.  The brightest people create the best solutions, so we take pride in continuously sharpening professional and personal competencies as well as assuring a steady flow of challenges. The development of our employees is the foundation for the growth of our business.

 

Your Talent

We expect you to hold a relevant university degree as engineer, or similar. You have experience within the Regulatory Affairs disciplines in relation to Medical devices, preferably in a large international organization.

 

You are self-motivated, positive and committed. You think business oriented and have the ability to organize and plan your tasks. It is important that you are focused, can prioritize and keep calm when deadlines are tight. Furthermore, you have a problem-solving approach and you should thrive in a fast-paced environment.

You are fluent in English, both written and spoken. In other words, you have a desire to support and enrich Oticon´ s culture.

 

You would love to work in a worldwide leading company, where knowledge sharing, and mutual professional respect makes it fun and meaningful to work.

 

How to apply

 

Please send your CV and motivation letter as soon as possible – deadline is 30th June 2019. We will already now be screening weekly and invite relevant candidates for interviews.  Please, we only accept applications through our online platform.

 

If you would like to know more about the position, you are very welcome to contact Senior Regulatory Affairs Officer, Louise Mejdal Jeppesen on phone +45 2094 4627

 

We are looking forward to hearing from you.