Regulatory Affairs Specialist

About This Role

The Regulatory Affairs Specialist supports Demant by managing regulatory strategy and project support throughout the product development process for medical devices. This role involves working in a fast-growing international organization, handling technical documentation, and participating in regulatory projects.

Responsibilities

• Maintain technical documentation for medical devices, including private label products
• Manage and document regulatory project strategy, classification and intended use, risk management file, standard requirements, and review of marketing materials
• Participate in regulatory projects
• Attend design review of design changes ECR
• Perform risk evaluation of design changes
• Handle ECO and update documentation relating to ECO
• Support other teams (RAP, RACA, RAFR) with creation and review of project deliverables

Requirements

• Good English skills enabling everyday communication
• Analytical and communication skills
• Ability to travel to Denmark at least two times per year
• Systematic approach to work, willing to get things done
• Self-driven approach and a strong team player who can develop and maintain good relations with stakeholders

Nice to have:

• Experience with Regulatory Affairs or working in the medical devices business or any other well-regulated areas (e.g., pharmacology) for at least a year
• Bachelor's degree in medicine, chemistry, pharmacy, or similar (educational background is not decisive)
• Experience of working with MS Office, Database Systems, and documentation systems

Benefits

• Full-time employment with an international and growing organization, with a permanent contract after 3 months
• Flexible working hours
• Possibilities of learning and development opportunities, adapted to your needs and supporting your growth
• Various training and development programs
• Daily use of English in an international environment
• International business trips
• Competitive benefits package including social benefits (private medical health care, insurance, sport card etc.)
• Possibility to join a team of high-performers where can-do-attitude, trust, and honesty are core values
• Scandinavian culture – informal, caring about equality, independence, open dialog, and work-life balance

Important Details

• Schedule: flexible working hours
• Contract: permanent after 3 months
• Work format: hybrid working model, combining remote work opportunities with the modern office

Application Process

• First meetings with candidates are planned to start in the second half of September 2026

About the Company

Demant has a small and dedicated team of 24 people situated in Poland and Denmark, responsible for regulatory strategy and project support throughout the product development process. The team manages classification activities, risk management file processes, clinical evaluation, device and facility registrations, radio approvals, electrical safety approvals, and standard and regulation requirements. Furthermore, the team is involved in external and internal audit and system compliance according to EN ISO 13485 and FDA 21 CFR 820 and is continuously involved in improvement projects.