Smørum

Certification Manager

Fakta

Lokation:
Smørum
Ansøgningsfrist:
30/04/2019
Afdeling:
Quality
Ansøg nu!

Certification Manager

Oticon is one of the best places to work for Engineers in Denmark. This is according to “Ingeniøren” - but why is that?

 

We believe it is our innovative work environment. For us, true engineering excellence is to deliver an ultra-small technological marvel in a discrete, user friendly package. This takes state-of-the-art development methods and serious engineering skills. We are a large, growth-oriented company and work within the financially stable medico-technical industry. Our 500+ engineers are empowered to communicate freely and participate actively.

 

The setting you are getting into

You can be part of this success by joining the Regulatory Affairs department, which consist of 16 highly dedicated people and is part of the Quality Assurance & Regulatory Affairs 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 must support R&D with RF, EMC and Safety strategy in relation to choice of test methods, reuse of approvals and how to deal with various countries. You will participate in different R&D projects as Certification Project Manager with focus on RF, EMC and Safety test approvals.

 

You will:

  • Initiate, create, and finalize RF, EMC and Safety budget
  • Identify relevant RF, EMC and safety standards for the product
  • Support the R&D project in interpretation of RF, EMC and Safety standards with respect to relevant markets
  • Communicate details about documentation and test samples needed to the R&D project
  • Collect test samples and arrange and participate in external testing, which may include traveling
  • Contact to test house and drive completion of testing in order to meet committed deadlines.
  • Maintain registrations in registration databases

 

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

You have a relevant university degree and competences within EMC, Electrical Safety and Bluetooth.

You will prepare certification strategies and negotiate with different test houses about RF, EMC and Safety approvals. You may have experience with creating, reviewing and handling RF, EMC and Safety test related documentation in R&D projects.

 

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 of April 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 Certification Manager in Regulatory Affairs, Per Klaus Nielsen on phone +45 4149 9503.

 

We are looking forward to hearing from you.