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.