Regulatory Affairs Specialist to Philips Healthcare, Solna
Experis Engineering / Maskiningenjörsjobb / Solna
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hela Sverige Philips - Sense and Simplicity
Millions of people around the world are making their lives easier with Philips products, services and solutions. It can be lights that show us the way, medical equipment which gives a mother the first view of her unborn child or a sound system that keeps a whole family excited. Together with us your thoughts and ideas will have a positive influence on people; Philips is there with you in your daily life.
Philips Healthcare is one of three Business Sectors. Philips' mission is to become the world's premier health and Well-being Company and we are now the world's second largest manufacturer of medical diagnostic equipment. Philips Healthcare is committed to providing innovative technology and services that enable healthcare providers to achieve clinical excellence without compromise.
Philips Mammography Solutions in Solna is part of a global organization that develops, produces and sells Digital Mammography equipment to hospitals. In Solna we stretch across the entire business and have marketing, R&D and production in-house. The strategy is to provide integrated solutions for breast cancer care. The product portfolio consists of a unique digital mammography solution based on photon-counting technology that enables excellent image quality with reduced X-ray radiation dose.
We are looking for a driven and quality conscious Regulatory Affairs Specialist for a one-year assignment. We believe the person we are searching for strives to excel, and will help us continue to fulfill applicable regulatory requirements and quality standards, in order to enable us to sell worldwide. We expect you to be well-educated, smart and professional, but also to have a sense of humor; life is too short not to have fun. Most of all we are looking for an open, committed person who shares our values.
Key Areas of responsibility:
You will work, as part of the Quality department, in close collaboration with all of our departments, mainly focusing on regulatory affairs.
However, since we are a small Q&R team, you are also expected to participate in the following areas: maintaining the quality system, perform internal audits, participate in incident management and risk analyses, participate in complaint reviews and CAPA management.
Qualifications:
For this position we have the following requirements:
Master of Science or equivalent.
Excellent communication skills, fluent in English and Swedish (verbal and written).
Experience in regulatory affairs, obtaining country approvals/registrations for medical devices, and knowledge of regulatory standards, e.g. IEC 60601.
Experience with ISO 9001, ISO 13485, QSR (CFR Title 21 Part 820) is a plus.
Interest and experience from process development and implementation
We also consider it a merit if you:
Speak more languages than those required above (tell us which) and have a background in the Med tech industry.
We offer you:
The possibility to work with high end technology in Med tech together with smart people in an international environment.
Be employed by a large organization but in a smaller entrepreneurial company culture where your voice will be heard.
The opportunity to work for a company that creates meaningful innovations that improve people's health and well-being.
Contacts:
For this position, Philips Healthcare is working with Experis Engineering.
The selection and interview process is ongoing, please send your application as soon as possible - do not wait until just before the closing date. If you have specific questions or trouble registering your application, you are welcome to contact recruitment consultant, Rutger Carlheim-Gyllensköld +46 (0) 8 764 25 72.
Publiceringsdatum2013-04-19Arbetstider och omfattningEnligt överenskommelse
ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2013-05-03
Ansökan kan tyvärr inte göras via e-post.
Klicka på denna länk för att göra din ansökanKontaktRutger Carlheim-Gyllenskiöld 08-764 25 72
FöretagExperis Engineering
AdressExperis Engineering
BOX 1125
11181 Stockholm
Jobbnummer 1527568
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