Regulatory Affairs Expert

HemoCue, a Danaher company since April 2013, is a global leader in Hb point-of-care testing. In 1982, HemoCue AB (Ängelholm, Sweden), introduced the first accurate, near-patient hemoglobin test. We offer point-of-care tests for hemoglobin, glucose, urine albumin, HbA1c, total and differential white blood cell count. Further information available at www.hemocue.com
Do you want to make a difference by developing and ensuring access to key lifesaving medical device products? All this in a 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 ever-evolving regulatory landscape around the world and understand the impact it might have on the HemoCue business and product portfolio. We are now looking for the right candidate that in the future will play an important role for the regulatory strategies to come for HemoCue.
You will be part of a RA team that today consists of eight people with different backgrounds, knowledge, and experience. As a RA Expert, you will be working in cross functional teams together with the other major functions withing the organisation e.g. R&D, Operations, Sales and Marketing, where you will be providing RA expertise and guidance to ensure safe, reliable and compliant products.
We offer you an exciting possibility to join our fantastic team creating tomorrows solutions for Point of Care testing making peoples life’s better.
Responsibilities
Monitoring, interpretation and communication of regulatory requirements
Support the organization in regulatory strategies for new product developments
Compilation and maintenance of regulatory submissions
Lead and coordinate regulatory Q&A sessions with regulatory authorities

Qualifications
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)
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
To succeed as a RA Expert you need to be systematic and flexible you also need to value and enjoy good teamwork. Furthermore we believe that a can do attitude and ability to prioritize in a fast paced environment is key. You also enjoy working in a company that aims to continuously improve, 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“.
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.
The position is a full-time position with flexible location we can offer you an office space in either our head office in Ängelholm or in our brand-new satellite office in Lund.
We are looking forward to receiving your application no later than September 15.
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.