Senior Regulatory Affairs Expert
HemoCue AB / Kemiingenjörsjobb / Ängelholm
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hela Sverige HemoCue, sedan april 2013 en del av Radiometer Group, är ett världsledande företag inom patientnära testning. HemoCue AB, beläget i Ängelholm, introducerade 1982 det första patientnära hemoglobintestet. Företaget säljer även patientnära tester för glukos, urinalbumin, HbA1c, totala antalet vita blodkroppar (B-LPK) och 5-partsdiff. Besök vår hemsida för mer information hemocue.com
Are you an expert in regulatory affairs within medical device? Do you have the experience to work with the US market and are an excellent communicator? Do you want to work for a truly global business who refuse to compromise when it comes to caring for people? If your answer is yes, you may be the candidate we are looking for!
The Job
HemoCue develops, produces and markets easy to use diagnostic systems for the Professional Point of Care markets. We are global market leaders in Hemoglobin testing and hold strong positions in other served product segments. 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 the right candidate that in the future will play an important role for the regulatory strategies to come for HemoCue.
You will be responsible for:
Monitoring, interpretation and communication of regulatory requirements
Ensure procedures and activities are in compliance with requirements
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
Participate in product development projects with regulatory expertise
You will report to the Director Regulatory Affairs and be placed in Ängelholm, Sweden.
We are offering a dynamic, innovative and challenging position where you will be able to work with regulatory affairs in an independent and global role.
Qualifications "Constructive Diversity" is one of our core values, and we believe that human diversity creates a dynamic and creative environment. Therefore, we encourage it through our recruitment process.
We are looking for a person with the following experience and qualification:
Master degree in Engineering, Pharmacy, Biology, Chemistry, or similar.
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
It is a great advantage to have knowledge of regulatory submissions for IVD products in the US
Project leader skills
Profound experience as MS Office user
You have excellent English in speech and writing, Swedish is an advantage
Personality On a personal level, you have excellent communications skills. You have the ability to work in a high matrix environment. You are self-motivated and you have the ability to plan and execute activities with minimal supervision. You strive to deliver results. We place great emphasis on personal qualities for this role.
Interviews will be held as soon as relevant candidates have been identified
• so please do not hesitate to apply. Start the application process by visiting our Career Site at
www.hemocue.com/jobbsidan and follow the guidelines. Please upload relevant documents and fill in as many fields as possible in the process. This will increase the chances of a right match and also put you in a better position if a similar job matching your requirements and skills should become vacant. We are not able to receive your application by other means than through "jobbsidan". 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.
For further information, please contact Director Regulatory Affairs Maria Fagerberg at tel. +46 734 140 346. Union information is available from, Mikael Godolakis, Unionen, +46 431 48 14 66 or Robert Harr, Akademikerföreningen, +46 431 48 14 25.
Organization/Business description:
Because When it Comes to Caring for People, We Refuse to Compromise
HemoCue, part of the Radiometer Group since April 2013, is a global leader in point-of-care testing. HemoCue AB (Ängelholm, Sweden), introduced in 1982 the first accurate, near-patient hemoglobin test. The company also sells point-of-care tests for glucose, urine albumin, HbA1c, total and differential white blood cell count. For further information, visit
www.hemocue.com .
HemoCue is operating in an important and growing global healthcare diagnostic segment - primary care. Currently an independent entity within Danaher, directly overseen by Radiometer Group, HemoCue is guaranteed an interesting and dynamic future, as DHR-Dx maximizes the value of its investment in HemoCue, by thinking HemoCue into the strategy to enter more POL market segments.
HemoCue is an environment where talent can own truly global, end-to-end value chain responsibility within any function, with all the complexity that this carries. HemoCue is a top-of-the-line career platform, both for HemoCue internal advancement, for advancement within DHR, and for advancement in other companies on the back of the DHR brand.
Varaktighet, arbetstid
40 timmar med flex Efter överenskommelse
Publiceringsdatum2017-10-09ErsättningEfter överenskommelse
Så ansöker duSista dag att ansöka är 2017-11-06
Klicka på denna länk för att göra din ansökanKontaktMaria Fagerberg +46 431 48 13 46, +46 734 14 03 46
FöretagHemoCue AB
AdressHemoCue AB
Box 1204
26223 Ängelholm
KontorsadressKuvettgatan 1
Jobbnummer 3740266
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