Regulatory Affairs Expert

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

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.

The main tasks

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 Assessment of potential reportable events and field actions
Qualifications

University degree in science or technology (Master or Bachelor) Proven good knowledge of regulations for IVD products, standards for quality management systems (ISO 13485, QSR) and risk management for medical devices (ISO 14971) Minimum of 3 years of experience of similar products and/or other medical devices Excellent communication skills (verbal as well as writing) in both English and Swedish Good PC skills (Word, Excel, Power Point etc)
It is important you take individual responsibility and have a positive attitude towards your work and others. The position has internal contacts with functional managers, team members, project participants and cross departmental cooperation. You will also have external contacts with Regulatory authorities, Subsidiaries and Distributors.

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 great challenges and experience. 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: December 1, 2016