Specjaliści

Regulatory Affairs Specialist

The most important resource of Össur is its staff. At Össur, we value our extensive skills and knowledge base and naturally we nurture a spirit of innovation.  With wide-ranging roles involved in our business, Össur is keen to attract talented individuals and accomplished team players, who are ready to contribute to the achievement of our goals.

 

We are a global leader in non-invasive prosthetics, including bracing and support products. As RA/QA Specialist at Össur, you will have responsibility for Regulatory Affairs, support of submissions and on-going regulatory compliance throughout the product life-cycle.

 

We offer a position in which you get a broad exposure within the Quality and Regulatory field within Europe and the Emerging Markets. As part of a newly established team in Poland you would be able to contribute to the development of the Q&R department at the location. We are open for candidates who have some experience in this field or relatable education and want to develop themselves further in this area.
 
Working with us you will receive:
•    full-time work agreement, with a permanent contract after 3 months; 
•    close collaboration with a cross-functional teams located in Eindhoven, Netherlands and Reykjavik, Iceland
•    flexible working hours;
•    possibilities to improve English by daily usage (courses offered);
•    relocation package if needed;
•    discounts on hearing aids after one year of employment (for employees and family members);
•    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 tasks are waiting for you?
•    Assure and maintain regulatory device product and facility registrations, listings, license renewals and annual registrations.
•    Monitor MDR, European and emerging markets regulatory environments and provide assessment on the new and changing regulations.
•    Support vigilance reporting as required and assure timely submission to health authorities and other organisations, as necessary.
•    Support documentation on all recalls, product safety issues, field actions and failures to health authorities as required.
•    Support maintenance of the quality management system for Össur in compliance with applicable industry standards and regulations as necessary.

 

It would be great if you have:
•    bachelor’s degree or equivalent experience;
•    working knowledge within Medical Device environment or equivalent;
•    ability to read, analyse, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations;
•    ability to write reports, business correspondence, and procedure manuals;
•    extensive computer knowledge in MS products;
•    advanced knowledge of English enabling everyday communication.


 

 

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
  • Imprezy firmowe
  • Zniżki na aparaty słuchowe
  • Karta sportowa
  • Owocowe wtorki i czwartki
  • Pakiet relokacyjny
  • Świadczenia świąteczne
Sprawdź wszystkie benefity

Zobacz także

Jakość i Rejestracja Wyrobów Medycznych
Regulatory Affairs Specialist
Lokalizacja:
Szczecin
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