Regulatory Affairs Manager
Philips AB / Övriga jobb / Stockholm
2016-10-12
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hela Sverige Your challenge
It is a special feeling to know that you, through your work, have contributed to improve People?s lives. We offer you an interesting job with good development prospects plus that special feeling.
You are a quality minded and experienced professional with a high knowledge about medical device directive-post-market surveillance activities. Preferably have a good understanding of ISO 9001, ISO 13485 and 21 CFR 820, looking for a challenging position within the Nordic Market organization and want to work in our office in Stockholm/Kista.
As a Regulatory Affairs Manager you:
• Are Responsible for providing regulatory support for all post market activities across the Nordic region.
• Drive compliance with the applicable regulations as laid down in the medical device directive, Philips Healthcare standards & policies for (but not exclusively) customer complaints, product field actions and product holds.
• Liaise with all our manufacturers sites and others for timely closure of actions relating to above mentioned areas
• Are the responsible key contact for communications with the Nordic competent authorities and distributors/dealers for above mentioned areas
• Regularly interacts with senior management and working with relevant parties to ensure timely response to requests for information/action
• Maintains and implements policies and practices related to post market activities
Your team
As Regulatory Affairs Manager you are supported by a post-market surveillance officer located in Stockholm/Kista and you will report to the
Head of Quality and Regulatory NORDIC.
Our offer
An interesting job, working with all stakeholders within the Nordic Market as well as with our international teams in the all market organization and our manufacturing sites. Good development prospects and opportunities for career paths within Philips.
We are looking for
• Successfully completed Bachelor or Master?s program
• At least 3 ? 5 years of professional experience within the regulatory affairs domain in medical devices industry
• A good understanding of the medical device directive and a high level understanding of post-market surveillance requirements including MEDDEV 2 12-1.
• A good understanding of post-market country regulations within Nordic as well as experience of clinical investigations for medical devices
• Knowledge/training on ISO 9001, ISO 13485 and 21 CFR 820 is an advantage
• Very strong communication plus a proactive and independent work style
• Fluent English skills and willingness to learn Swedish
Contact
If you?re interested in this opportunity to join us, please upload your resume and motivation letter through the application button. .
Varaktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2016-10-12ErsättningFast och rörlig lön
Så ansöker duSista dag att ansöka är 2016-10-24
Ansökan kan skickas till e-postadress:
florian.kalvelage@philips.comFöretagPhilips AB
AdressPhilips AB
16485 STOCKHOLM
KontorsadressKNARRARNÄSGATAN 7
KISTA
Övriga kontaktuppgifterTelefonnummer: 08-59852000
Jobbnummer 3101122
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