Senior Regulatory Affairs Development Specialist

We are looking for a Senior Regulatory Affairs Development Specialist responsible for ensuring regulatory compliance in the design and development of new Diagnostics products, including audiometric accessories and audiology consumables. The role includes leading regulatory strategy from early development stages, preparing core regulatory documentation, supporting initial market approvals (EU MDR, FDA, global markets), and ensuring a smooth handover to the Product Lifecycle team. You will act as a key regulatory partner for cross-functional teams and help deliver safe, compliant, and innovative hearing and balance diagnostic technologies to global customers.

What we offer:

• Strategic role influencing the future Diagnostics product portfolio.
• Collaboration with R&D, Quality, Product Management, and other stakeholders.
• Global work environment with strong growth opportunities.
• Full‑time permanent role in a hybrid work model.
• Scandinavian work culture focused on openness, equality, dialogue, and work‑life balance.
• Opportunities to shape regulatory and compliance strategies across Demant Diagnostics brands.
• International team with colleagues in Poland and Denmark.

Your responsibilities:

• Lead regulatory strategy for development projects, including approval pathways and documentation requirements.
• Provide regulatory support for accessories and consumables.
• Act as the primary regulatory point of contact for development teams.
• Ensure timely delivery of regulatory inputs for first‑market approvals and handover to PRRC and Regulatory Affairs Product Lifecycle.
• Prepare and manage regulatory documentation, including design documentation review, regulatory file maintenance (strategy, labelling, risk, usability), EU MDR Technical Documentation, and US FDA 510(k) submissions.
• Support and maintain QMS processes related to Regulatory Affairs Development and contribute to lifecycle processes such as risk management and usability engineering.

What we hope you bring:

• Degree in engineering, life sciences, biomedical sciences, regulatory affairs, or a related field.
• Minimum 3 years of experience in regulatory compliance, preferably in the medical device industry.
• Strong knowledge of EU MDR 2017/745, FDA 21 CFR, MDSAP, and ISO 13485.
• Proven ability to structure and manage technical documentation.
• Ability to work independently and in international teams.
• Strong verbal and written communication skills in English.
• Preferably experience with ISO 14971, IEC 62366‑1, and ISO 10993.