Regulatory Affairs Expert

Do you want to make a difference by developing key lifesaving medical device products? In a truly global business who refuse to compromise when it comes to caring for people.
It is vitally important for the company to stay on top of the changing regulatory environment around the world and understand the impact it might have on the HemoCue business and portfolio. We are now looking for a candidate that will strengthen our Regulatory Affairs team during 12 months.
Responsibilities
Monitoring, interpretation and communication of regulatory requirements
Participate in product development projects with regulatory expertise
Support organization in regulatory questions
Review and approval of labelling and marketing material
Compilation and maintenance of regulatory submissions
Lead and coordinate regulatory Q&A sessions with regulatory authorities
Ensure procedures and activities are in compliance with requirement

Qualifications
Previous experience and good knowledge of international registrations
Proven good knowledge of regulations for IVD products (EU IVDD/IVDR, US FDA regulations 21 CFR), standards/regulations for quality management systems (ISO 13485, QSR) and risk management for medical devices (ISO 14971)
Minimum of 5 years of experience of similar products and/or other medical devices
Profound experience as MS Office user
Fluent in English and Swedish verbally and in writing

Personality
As a person you are a team player, systematic, structured and who likes a fast pace. You find it easy to communicate with other people and enjoy working in a company that is driven by continuous improvement, both in terms of equipment and processes.
Interviews will be held as soon as relevant candidates have been identified
Send your application via www.hemocue.com/careers. We are not able to receive your application by other means than through “careers site“. Please bring diplomas for face-to-face interviews. Any application by mail or e-mail will be returned.
We offer you
A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Sweden and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for training and career development.
We are looking forward to receiving your application no later than September 30.
For further information, please contact Director Regulatory Affairs, Rikard Almåker at tel. +46 734 14 03 89.
Union contacts: Björn Bylander, Unionen, +46 431 48 12 87 or Elin Söderlind, Akademikerföreningen, +46 431 48 12 62.
About Danaher
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries. A globally diverse team of 71,000 associates, we are united by our culture and operating system, the Danaher Business System, which is our competitive advantage. In 2014, we generated $19.9B in revenue and our market cap exceeded $60B. We are #149 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20yrs.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.