Regulatory Affairs Specialist
At Embla Medical, we are dedicated to improving people’s mobility. We do this with compassion and innovation, from how we design our award-winning mobility solutions to how we operate our network of patient care clinics.
Embla Medical is home to Össur, a leading global provider of prosthetics and bracing and supports solutions; FIOR & GENTZ, an innovative developer of neuro orthotics; and College Park, creators of custom-built prosthetic solutions for people of all activity levels. Since 1971, we have produced more than 2,100 patents and numerous award-winning designs, renowned advancing the Orthotic & Prosthetic (O&P) industry.
Our patient care clinics make up a vast network, spread across multiple countries.
At the position of Regulatory Affairs Specialist you will support one of our brand – Össur. In this role 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.
Working with us you will receive:
- full-time work agreement in the international developing organization;
- possibility of remote work within Poland;
- 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);
- various discounts (catering, cultural and art, discounts for cinema tickets, Netflix, books or e-books etc.);
- social benefits (private medical health care, insurance, sport card, etc.).
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 Embla Medical in compliance with applicable industry standards and regulations, as necessary.
Apply today if you have:
- Have Bachelor’s Degree or equivalent experience.
- Worked within Medical Device environment or equivalent.
- Are able to read, analyse, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Know how to write reports, business correspondence, and procedure manuals.
- Have extensive computer knowledge in MS products.
If you have any questions related to this job offer you can contact with recruiter Jakub - jkby@demant.com
Please send your CV in English.
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