Senior Regulatory Affairs Expert
HemoCue AB / Logistikjobb / Ängelholm
2015-12-21
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hela Sverige 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. Further information, visit
www.hemocue.com .
Senior Regulatory Affairs Expert
Challenging position for an RA Specialist with international experience and knowledge of IVD products. HemoCue is a market leader within point-of-care testing and represented in more than 130 markets worldwide. For their North & South American markets, we are looking for an experienced professional, who will participate in the regulatory processes, from the products are developed in R&D till they are launched in the markets.
The role is highly exposed to stakeholders in R&D, Sales & Marketing and towards partners and subsidiaries in the local markets. There will be local support from external legislative advisors in connection with the RA projects.
The position is placed in Ängelholm.
The Job
As Senior RA Expert, your responsibilities will cover registrations, monitoring of legislations and to a smaller degree updates in the Quality Management System in connection with internal audits. The main part of your time will be centered on registration. Your primary tasks are:
Compilation and maintenance of regulatory submissions Lead and coordinate regulatory Q&A sessions with regulatory authorities Participate in product development projects with regulatory expertise Monitoring, interpretation and communication of regulatory requirements Ensure procedures and activities are in compliance with requirements Support the organization in regulatory questions Review and approval of labelling and marketing material
The success criteria will be your ability to communicate with and engage your stakeholders in ensuring that your projects are executed on time and where you have identified all risks and opportunities associated here with.
The Profile
We expect that you present yourself as a person who takes individual responsibility and has a positive attitude towards your work and others. You demonstrate excellent communication skills both verbally as well as in writing. You are able to go into depth with analyses and detect the risks associated with your projects. You also take great pride and ownership in your projects, and are comfortable having a lot of room to navigate. Besides your personal competencies, your professional skills include:
A university degree on bachelor or master level in Science or Technology Experience with regulations for IVD products Minimum 5 years of experience of similar products and/or medical devices Preferably also knowledge for standards for quality management system and risk management for medical devices Also, it is an advantage that you have experience with the North & South American markets. Alternatively, you have experience operating with international registrations
The Organization
There are 5 people in RA, working with RA and vigilance, and they are part of the RA/QA organization that comprises Quality Assurance, RA, Design Quality Management and Compliance. The team collaborates closely with the rest of the organization and is a key player in ensuring that HemoCue stays on top in the changing regulatory environment around the world and understands the impact it might have on the HemoCue business and portfolio.
Contact Information
For more information you are welcome to contact HR Director, Christina Jonéus +46 73345 72 03
Please send your application and resume in English to
www.hemocue.com/jobbsidanAbout HemoCue
HemoCue is a company that gives a unique opportunity from a regulatory perspective. Being a global leader and serving over 100 countries in the world with POCT products of highest quality gives the employees great challenges and experience. HemoCue is part of Danaher, a successful $20 billion NYSE listed conglomerate with many companies in the medical device industry.
HemoCue is a global leader in a field of diagnostics known as near patient, or point-of-care, testing. In 1982, HemoCue AB, based in Ängelholm, Sweden, introduced the first system making accurate hemoglobin testing possible in near-patient settings. Since then, more than 400,000 HemoCue systems have been sold worldwide. The company also sells point-of-care tests for glucose, urine albumin, HbA1c, total and differential white blood cell count. HemoCue subsidiaries, affiliates, franchises, and third-party distributors generate revenue in more than 130 countries worldwide. Since April 2013 is HemoCue part of the Radiometer Group. Additional company information is available at hemocue.com.
Varaktighet, arbetstid
40 timmar Enl överenskommelse
Publiceringsdatum2015-12-21ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2016-01-04
Klicka på denna länk för att göra din ansökanKontaktMaria Fagerberg +46431-481346, +46 734 14 03 46
FöretagHemoCue AB
AdressHemoCue AB
Box 1204
26223 Ängelholm
KontorsadressKuvettgatan 1
Övriga kontaktuppgifter Jobbnummer 2587638
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