Regulatory Affairs Specialist in Sweden or in Denmark

Our journey has begun, do you want to join?

We are a Quality & Regulatory Affairs team of five, based in the office in Askim, Gothenburg, Sweden.

Depending on the candidate´s preference, this position can be based in either Gothenburg, Sweden or in Copenhagen, Denmark.

We are responsible for ensuring regulatory product compliance of our products globally as well as managing the Quality management system. It is our job to ensure the establishment and maintenance of the products technical files, set regulatory strategies for our products and guide the organisation in quality system compliance.

To describe your team in the best way, we believe in a collaborative, supportive 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 cross-functional team effort.

We work interdisciplinary and across countries. Hence, you should expect to travel around 15 days annually.

Responsibilities in short
You are regulatory responsible for an assigned product area
You are part of the project core team representing QARA.
You establish and maintain the product technical file and drive the risk management activities.
You prepare the CE-marking file and FDA submission.
You support the marketing team with review of product claims.
You support the clinical team with documentation and strategies for clinical trials.
You drive the post market surveillance process for assigned products area.
And most importantly you are everyday a link between different functions to facilitate cross functional work.




What we are looking for

To do a good job, you need to have strong product focus, be curious of new products and interested in new technologies and in how things work. This also means you find it easy to convert and translate between technical challenges and documentation and regulatory demands. Preferably you have a technical background or experience from electronics and software.

The basics to perform well:


You have at least 2 years working with QA/RA within medical devices area. You have established knowledge of MDD, AIMDD, MDR, ISO 13485, and QSR.

As we are a global company, you communicate effortlessly in English and are used to write in English.

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 25th of May 2020, by using the link “Apply now”.

Don’t hesitate to reach out


For more information about the job, please contact Birgitta Bolander, Head of Quality & Regulatory Affairs on bibo@oticonmedical.com

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

Recruitment agency? Thank you for your interest, but we are sourcing all our candidates directly or via our preferred suppliers. We appreciate you trying but please keep in mind that any unsolicited profiles you send us will be treated as direct applications from the candidates.

We are excited to hear from you.


Because sound matters
Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the magical world of sound to people at every stage of life. As part of the Demant group, a global leader in hearing healthcare with 15,000 people in over 130 countries, we have access to one of the world’s strongest research and development teams, the latest technological advances and insights into hearing care.


Our competencies span more than a century of innovations in sound processing and decades of pioneering experience in hearing implant technology. We work collaboratively with patients, physicians and hearing care professionals to ensure that every solution we create is designed with users’ needs in mind. We share an unwavering commitment to provide innovative solutions and support that enhance quality of life for people wherever life may take them.


Because we know how much sound matters.