Regulatory Affairs Manager

Because sound matters

Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the power of sound to people at every stage of life. For more than a decade, we have made bone anchored hearing systems more accessible by simplifying the treatment for physicians, audiologists, and patients alike.

We believe that patients and hearing care professionals should be able to choose the best possible solution at any time along the patient journey. We call it “Freedom of Choice” and it has always been paramount to Oticon Medical. This is the reason why our solutions are designed to be compatible whenever possible. As a result, an implant from Oticon Medical stands as a true testament to our unwavering lifelong support.

We work collaboratively with professionals to ensure that every solution we create is designed with our users’ needs in mind. We have a strong passion to provide innovative solutions and support that enhance quality of life and help people live life to the fullest – now and in the future.

Because we know how much sound matters.

Regulatory Affairs Manager

Are you passionate about improving lives through medical devices? Do you have experience in regulatory affairs? Join us as a Regulatory Affairs Manager at Oticon Medical.

At Oticon Medical, we develop and market bone-anchored hearing systems to help people with hearing impairment. Our product portfolio ranges from class I to class III medical devices, electronic devices, software, implants, surgical instruments, and accessories.

As a Regulatory Affairs Manager at Oticon Medical, you will be the regulatory expert for an assigned product area, ensuring compliance throughout development and post-market phases. The product area assigned to this position is sound processors, software and related accessories.

Your Role

As Regulatory Affairs Manager, you will:

Represent QARA in cross-functional development projects. Set regulatory strategies and guide development projects in QMS compliance. 
Establish the products technical file and drive risk management activities
Review and summarize scientific and technical data and support the developers in relation to requirements, testing and acceptable deviations
Manage submissions for CE-mark and FDA clearance and support RoW registrations
Support the marketing and product management teams with review regarding product claims when developing product labeling and campaigns.
Support the clinical team with documentation and strategies for clinical trials.
Ensure that the regulatory compliance is maintained for in market products, assess product changes and drive updates to new regulations.

Your Profile

You have a technical background preferably with experience from active medical devices and electrical safety. Experience with software, cyber security and EMC, BLE is highly beneficial as well. You are pragmatic, have strong product focus and an ability to convert and translate between technical challenges, documentation and regulatory demands.

3+ years of experience in QA/RA, preferably in medical devices.
Strong knowledge of MDR, ISO 13485, MDSAP, and QSR.
Communicate effortlessly in English.
Willingness to travel (~10 days/year).

Why Oticon Medical?

Join a collaborative and dynamic team in a trust-based environment where innovation drives better hearing solutions. We’re a fast-growing company dedicated to making a difference in people’s lives through advanced hearing solutions.

Apply Now!

Submit your CV and application through our online system by 2025-03-30. We do not accept applications via email. Please note as well that the position might close before last application date, so don’t hesitate to apply.
For questions, contact Karolin Isberg Jernby, VP Operations QARA, kije@oticonmedical.com.

Apply now »