Regulatory Affairs Specialist

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 20 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, device and facility registrations, radio approvals, electrical safety approvals plus standard and regulation requirements. Furthermore, the team is involved in 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 agreement in an international organization, with a permanent contract after 3 months;
• flexible working hours;
• a hybrid work model, combining remote work opportunities with work in an office in the City Center;
• possibilities to improve English by daily usage (courses offered);
• relocation package if needed;
• great opportunities for usage of newest technology;
• discounts on hearing aids after one year of employment (for employees and family members);
• various discounts (catering, cultural and art (Netflix, books or e-books etc.));  
• social benefits (sport's cards, medical health care and so much more);
• 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 material.   
• 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.

Apply 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 four 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.

We are looking for your application!

If you need more information, please contact with recruiter Justyna (jupn@demant.com)

Furthermore we would like to inform you that the company has an internal reporting procedure, which is available at: https://demant.codeofconduct.app/
 

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