Regulatory Affairs Manager

Shape the Future of Hearing Care - Regulatory Affairs Manager 

- Do you want your regulatory skills to directly improve people’s lives?

At Oticon Medical, we develop innovative bone‑anchored hearing systems that give people with hearing impairment access to better hearing – and a better everyday life.

We are now looking for a Regulatory Affairs Manager to take regulatory ownership of our sound processors, software, and accessories and play a key role in our product development and lifecycle management.

Why This Role Is Worth Applying For

• Role with direct responsibility for product decisions and patient outcomes.
• Broad regulatory scope (Class I–III devices, MDR, FDA, global markets).
• Close collaboration with R&D, Clinical, Marketing, and Product Management.
• Trust-based, pragmatic culture where regulatory know-how enables innovation.
• Growing company with a solid commitment to quality and continuous improvement.

Your Mission – if you choose it

As Regulatory Affairs Manager for this newly created position, you serve as the primary regulatory authority for sound processors, software, and accessories, overseeing compliance from early development through post‑market activities at our site in Smørum.

You enable rapid progress without sacrificing patient safety or regulatory standards.

This is a position you really can put in your own footprint.

What You’ll Be Doing

• Represent QARA in cross-functional development projects and define regulatory strategies.
• Guide development teams in QMS and regulatory compliance.
• Establish and maintain Technical Documentation / Technical Files.
• Lead risk management activities throughout the product lifecycle.
• Lead CE marking under MDR and FDA submissions, and support registrations in RoW markets.
• Review product claims for labeling, IFUs, and marketing materials.
• Regulatory ownership of type approvals including radio/wireless approvals, EMC/electrical safety and software/cybersecurity compliance for sound processors and accessories
• Strategic oversight and subject matter expert within the area of type approvals.

You will report to Anders Johansson, Director QARA who comes with 25+ years of experience in the area of medical devices. Besides Anders, your closest professional sparrings partners are two Quality Assurance Managers and four Regulatory Affair Managers with expertise in implants, all located in Gothenburg. On top of that you will also have sparrings partners in Nice, where we have our production site.

You will have a local host manager in Smørum who will take care of everything you need in your daily life in Smørum. We are present over 120 employees and all look forward to taking good care of you.

What You Bring

• 3+ years of experience in Regulatory Affairs or Quality within medical devices.
• Solid knowledge of EU MDR, ISO 13485, MDSAP, and FDA QSR.
• Technical understanding of active medical devices. (Experience with software, cybersecurity, electrical safety, EMC, BLE/connectivity is a strong advantage.)
• A pragmatic, product-focused mindset with the ability to translate regulatory demands into practical solutions.
• Effective communication abilities and confidence engaging with a variety of stakeholders
• Fluency in English.
• Willingness to travel approximately 10 days per year.
• Capable of working from Smørum from day one.

Why Oticon Medical?

At Oticon Medical, we combine cutting-edge technology with genuine purpose. You’ll be part of a cooperative team where regulatory professionals act as trusted advisors rather than gatekeepers.

We believe great solutions are created when people are empowered, heard, and supported—and we’re proud to develop products that truly change lives.

We were recently separated from Demant, which means we will move location somewhere in the future – but still near Copenhagen. We have very much a start-up mentality. For us it is fun to have all the knowledge and experience previously being part of Demant but now being able to set new directions for our products without being burdened by old legacy. It gives us some completely new possibilities.

Ready to become part of Oticon Medical?

Can you see yourself creating high quality and top service – and helping people to have a better everyday life? Then send a short application and CV no later than 10th of May 2026.

Expected interviews:

1st interviews: 13th of May 2026.

2nd interviews: 22nd of May 2026.

Please note: We only accept applications via our online platform, and we are not interested in inquiries from external suppliers.

If you have any questions or are curious to hear more, you are very welcome to contact: Anders Johansson, Director QARA: arnj@oticonmedical.com.

We look forward to hearing from you! .  #LI-HYBRID#LI-BS1