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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