Regulatory Affairs Expert

HemoCue AB / Kemiingenjörsjobb / Ängelholm
2017-07-04
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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

Temporary during 12 months

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 a candidate that will strengthen our Regulatory Affairs team during 12 months.

The main tasks

As a Regulatory Affairs Expert, your responsibilities will cover:

assessment of potential reportable events and field actions, communication with Health Authorities and coordination of needed actions
compilation and maintenance of regulatory submissions
lead and coordinate regulatory Q&A sessions with regulatory authorities
support organization in regulatory questions
The success criteria will be your ability to communicate with and engage your stakeholders in ensuring that your projects and activities are executed on time and where you have identified all risks and opportunities associated here with.

Qualifications

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 3 years of experience of similar products and/or medical devices
Preferably also knowledge in standards for quality management system and risk management for medical devices
Interviews will be held as soon as relevant candidates have been identified.

• so please do not hesitate to apply in English. 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. 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 offer

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 experience as well as challenges. In addition, being part of Danaher a successful $20 billion NYSE listed conglomerate with many companies in the medical device industry, the right candidate may find longer term development opportunities beyond HemoCue.

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.

For further information, contact Regulatory Affairs Director, Maria Fagerberg, +46 431 48 13 46, +46 734 14 03 46.

For trade union issues contact Patrik Heimby, Unionen, +46 431 48 14 10 or Lars Bergman Akademikerföreningen, +46 431 48 15 60.

Start the application at our Career Site at www.hemocue.com/jobbsidan .

Last application date: August 21, 2017

Varaktighet, arbetstid
Vikariat 12 månader 12 efter överenskommelse

Publiceringsdatum
2017-07-04

Ersättning
Enligt överenskommelse

Så ansöker du
Sista dag att ansöka är 2017-08-21
Klicka på denna länk för att göra din ansökan

Kontakt
Maria Fagerberg +46431-481346, +46 734 14 03 46

Företag
HemoCue AB

Adress
HemoCue AB
Box 1204
26223 Ängelholm

Kontorsadress
Kuvettgatan 1

Jobbnummer
3589198

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Regulatory Affairs Expert

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