Director QARA

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.

Director of Quality Assurance & Regulatory Affairs

Do you want to help us reach our vision, life where hearing loss is not a limitation. At Oticon Medical, we develop and market bone-anchored hearing systems. Our product portfolio ranges from class I to class III medical devices, electronic devices, software, implants, surgical instruments, and accessories.

We are now seeking a highly skilled and experienced Director of Quality Assurance & Regulatory Affairs to lead and further strengthen our QARA organization. Reporting to the VP QARA & Operations you will be overall responsible for the Oticon Medical Quality Management System (QMS) and regulatory compliance ensuring we can obtain and maintain the quality certificates and regulatory approvals necessary to sell our products

Key Responsibilities:

Develop the QARA organization, manage personnel, competence, resources and budget

Set regulatory strategies and secure product regulatory compliance and approvals worldwide.

Drive continuous improvement of our Quality Management System (QMS) securing patient safety and organization cross functional efficiency

Host external audits and act as the primary contact for authorities and notified bodies.

Support the organization and secure high quality and regulatory awareness

Qualifications:

Bachelor's degree in engineering, law, medicine, or administration.

5+ years of experience in the medical devices or pharmaceutical industry.

2+ years of personnel management experience.

Strong understanding of relevant laws, standards, and regulatory frameworks including but not limited to ISO13485, MDSAP, MDR 2017/745, FDA

Excellent leadership and management skills.

Preferred Competencies:

Role model for ensuing efficiency and pragmatism

Strategic focus and customer-oriented approach.

Holistic understanding of the business

Action-oriented mindset

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.

Submit your CV and application through our online system by 2025-04-01. 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

Recruitment Agencies: We appreciate your interest, but we are handling recruitment directly or through our preferred suppliers. Any unsolicited profiles will be treated as direct applications.

Apply now »