Regulatory Affairs Specialist

Demant Polska; Województwo zachodniopomorskie; Hybrid; PLN 112.000 - 167.000; Vollzeit

Benefits dieser Stelle

Private medical care

Insurance

Sport card

Training programs

Daily English in international env.

International business trips

Zusammenfassung

Demant Polska is seeking a dedicated Regulatory Affairs Specialist to join our small, international team in Szczecin. You will support classification activities, risk management, clinical evaluation, and device registrations across projects, with scope for travel to Denmark.

You will work in a hybrid model with flexible hours and opportunities for learning and development, contributing to compliance with EN ISO 13485 and FDA 21 CFR 820 in a dynamic environment.

Qualifikationen

• Experience in regulatory affairs or regulated medical devices (1+ year)
• Bachelor degree in medicine, chemistry, pharmacy, or similar
• Familiar with MS Office and documentation systems
• Strong English for daily communication

Aufgaben

• Maintain technical documentation for medical devices
• Manage regulatory project strategy and risk management files
• Attend design reviews and perform risk evaluations
• Support RAP, RACA, RAFR teams with deliverables

Kenntnisse

Regulatory Affairs

Medical devices

Risk management

Documentation

Regulatory projects

Ausbildung

Bachelor degree in medicine/chemistry/pharmacy

Tools

MS Office

Database systems

Documentation systems

Jobbeschreibung

Would you like to work with products that actually change the lives of people worldwide and do it in a fast-growing company? Then we can offer you the right challenge! Right now, we are looking for a dedicated and skilled Regulatory Affairs Specialist to support Demant. If you already have experience with Regulatory Affairs or any other well-regulated areas it would be great, but not necessary.

Working with us gives you the opportunity not only to plan your own work and be largely self-managed, but also to become a part of an experienced team of specialists capable of working in a dynamic and challenging international organization.

We are a small and dedicated team of 24 people situated in Poland and Denmark and we are responsible for the regulatory strategy for each project and for project support throughout the product development process.

Among other tasks, the team is managing classification activities, risk management file processes, clinical evaluation, device and facility registrations, radio approvals, electrical safety approvals plus 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 we are continuously involved in improvement projects.

Working with us, you will receive:

• full-time work employment with an international and growing organisation, with a permanent contract after 3 months;
• flexible working hours;
• a hybrid working model, combining remote work opportunities with our modern office located in the City Center of Szczecin;
• possibilities of learning and development opportunities, adapted to your needs and supporting your growth;
• various training and development programmes;
• 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 the core values;
• Scandinavian culture - we are informal (we don't use titles: Sir, Mr, Mrs, Miss...) and care about equality, independence, open dialog and work-life balance
• work with fantastic manager: Katarzyna Gajewska | LinkedIn

What tasks are waiting for you?

• Maintaining technical documentation for the Medical devices including documentation for private label products.
• Managing and documenting the regulatory project strategy, classification and intended use, risk management file, standard requirements, and review of marketing materials.
• Participation in Regulatory projects.
• Attendance in design review of the design changes ECR. Performing risk evaluation of the design changes. Handling of ECO, updating documentation relating to ECO.
• Supporting the other teams (RAP, RACA, RAFR) with creation and review of project deliverables.

It would be great if you have:

• experience with Regulatory Affairs or you work in the medical devices business or any other well-regulated areas (e.g. pharmacology) for at least a year will be an advantage;
• bachelor degree in medicine, chemistry, pharmacy or similar but your educational background is not decisive;
• experience of working with MS Office, Database Systems and documentation systems;
• good English skills enabling everyday communication;
• analytical and communication skills;
• ability to travel to Denmark at least two time per year;
• systematic approach to your work, willing to get things to be done;
• self-driven approach but the same time you are a strong team player who can develop and maintain good relations with stakeholders.

Considering the summer holiday period, we plan to start the first meetings with candidates in the second half of September 2026.

#Demant_Poland, ,