Informacje o stanowisku

Would you like to work with products that 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 Homologation Specialist to support Demant. If you already have experience with homologation 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 23 people situated in Poland (9 people) and Denmark (14 people), and we are responsible for the regulatory strategy for each project and for project support throughout the product development process.

Among other tasks, the RA 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 and hybrid workplace;
• a hybrid work model, combining remote work opportunities with work in an office in the City Center;
• possibilities of learning and development opportunities, adapted to your needs and supporting your growth;
• 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 (private medical health care, insurance, sport card, etc.);
• Scandinavian culture – we are informal (we don’t use titles: Sir, Mr, Mrs, Miss…) and care about Diversity, Equity, and Inclusion, independence, open dialog and work-life balance;

Your responsibilities include:

• Collect and submit relevant data for authorities.
• Cooperate with external stakeholders regarding registrations.
• Work with regulations.
• Collect documentation packages for registration purposes.
• Monitor and communicate regulatory changes.
• Maintain and update regulatory registration documents.
• Communicate with internal and external stakeholders.
• Other administrative tasks.

Apply if you:

• have a bachelor’s degree in law, administration, medicine, chemistry, pharmacy or similar, but your educational background is not decisive;
• are fluent in English, both written and spoken, and you have good communication skills;
• have experience in working with documentation management;
• have a sense for details without losing the overview;
• are proactive and outgoing with a strong will to learn;
• are a team player and thrive in a fast-paced environment;
• have experience dealing with regulatory work in the medical devices business or any other well-regulated areas - it would be great, but not necessary;
• enjoy working with computers, systems, and databases;
• are a self-managed and organized person with a structured and disciplined work approach;
• are willing to travel to Denmark for training and coordination purposes when required.

Please send your CV in English.

If you need more information, please contact recruiter Justyna at .

Szczecin - Oferty pracy w okolicznych lokalizacjach