Gothenburg

Regulatory Affairs Specialist

Fakta

Lokation:
Gothenburg
Ansøgningsfrist:
23/10/2019
Afdeling:
Regulatory Affairs
Ansøg nu!

Regulatory Affairs Specialist

Developing implantable hearing aids that truly make a difference to hearing impaired is our mission. We are all passionate about ensuring high life quality. This can also become your mission as we are hiring.

 

Our background story

Oticon Medical AB is part of Demant Group. Demant is a world-leading hearing healthcare group that offers solutions and services to help people with hearing loss connect and communicate with the world around them. For more than a century, the Demant Group has played a vital part in developing innovative technologies and know-how to help improve people’s hearing and health. In every aspect, from hearing devices, hearing implants and diagnostic equipment to hearing care all over the world, Demant is active and engaged. We employ more than 14,500 world-wide and are a growing business in intelligent audio solutions for gaming and office communication is also a significant part of the Group.

 

Our journey has begun, do you want to join?

We are a team of three, based in the office in Askim, Sweden. We are responsible for ensuring regulatory product compliance. We are responsible for product registrations worldwide and guidance for quality system compliance during development projects. We follow AIMD, MDD, ISO 13485, and QSR etc.

 

To describe your team in the best way, we believe in a collaborative and open culture. We depend on each other to share know-how’s and challenges because we believe that the best results come from a fruitful team effort. We work interdisciplinary and across countries with our colleagues in Copenhagen and Nice. To ensure sufficient collaboration with the projects you are expected to spend 1-2 days a month in our offices in Denmark and / or France.

 

Responsibilities in short

We would like to give you a peak into what you might expect to work with, and this might be tricky, as you will see that our days are not the same.

 

You will primarily work with product development projects related to our bone-anchored hearing solution with regulatory focus.  You are representing QA/RA in assigned projects and we wish for you to utilize your expertise with providing guidance in quality system compliance as well as regulatory compliance. You need excellent planning skills to establish the regulatory plans on assigned projects.

 

Furthermore, you lead the accomplishment of risk management activities in the projects. You hold the role in securing establishment and regulatory compliance of product documentation and perform product registrations worldwide, either directly or through distributors.

 

A part of your job is also to support development of product labelling and ensure compliance with product claims and achieved product registrations.

 

With the new Medical Device regulation taking affect in May 2020, we need to be well-prepared. We are already implementing the changes in our current product portfolio and for the future. This means that you will also have an important role in supporting the implementation.

 

What we are looking for

You are passionate about efficiency, structure and regulatory compliance and understand the challenges of working in a fast-growing environment.

 

The basics to perform well:

  • You have at least 3 years working with QA/RA, preferably with medical devices. You have a thorough understanding of AIMDD or MDD, ISO 13485, and QSR.
  • As we are a global company, you communicate effortlessly in English and are used to write in English. If you have French or Spanish language proficiency we consider this as meriting.

 

We know you can! 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 participate developing our ways of working.

 

Want to see it from our side?

To apply for this position please attach your CV and short motivational letter in English not later than October 23, 2019, by using the link “Apply now” at our website. 

Please note that we only accept applications send through our online web platform but it can tease so please have patience.

 

Don’t hesitate to reach out

For more information about the job, please contact Satu Hjärtstam, Head of Regulatory Affairs on +46 735 44 98 13 .

If you have questions to the recruitment process please reach out to Ditte Mi Petræus on +45 5381 3547

 

We are excited to get to know you.