Homologation 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 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 20 people situated in Poland (7 people) and Denmark (13 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 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, with a permanent contract after 3 months;
•    flexible working hours;
•    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);
•    possibility of hybrid system work;
•    various discounts (catering, cultural and art, discounts for cinema tickets, Netflix, books or e-books etc.);  
•    social benefits;
•    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.

What task are waiting for you?

•    Collect documentation packages for international approvals.
•    Collect information and create homologation overviews.
•    Participate in homologation projects.
•    Be responsible for your own countries.
•    Handle communication with our local representatives around the world for the purpose of registering products.
•    Monitor and communicate changes in country specific requirements to relevant stakeholders.
•    Maintain and update regulatory documents.
•    Communication with internal and external stakeholders.

It would be great if you: 

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



Oferty z poniższą klauzulą prosimy przesyłać za pomocą przycisku „Aplikuj”.

Uprzejmie informujemy, że nadesłanych dokumentów nie zwracamy. Jednocześnie zastrzegamy sobie możliwość do kontaktu tylko z wybranymi kandydatami.

Powody, dla których warto z nami pracować:

  • Prywatna opieka medyczna
  • Domki letniskowe w Danii
  • Bezpłatne autobusy lub dopłata do komunikacji miejskiej
  • Imprezy firmowe
  • Zniżki na aparaty słuchowe
  • Karta sportowa
  • Owocowe wtorki i czwartki
  • Pakiet relokacyjny
  • Świadczenia świąteczne
  • Darmowa kawa, herbata
  • Karta zniżkowa do pobliskich restauracji/sklepów
  • Dofinansowanie do nauki języka
Sprawdź wszystkie benefity

Zobacz także

Jakość i Rejestracja Wyrobów Medycznych
Homologation Specialist
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