Regulatory Affairs Manager
Philips AB / Sjukhusteknikerjobb / Stockholm
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Kort beskrivning av företaget:
Philips is a Dutch technology company headquartered in Amsterdam with primary divisions focused in the areas of electronics, healthcare and lighting. It is one of the largest electronics companies in the world and employs around 105,000 people across more than 60 countries. Philips is organized into three main divisions: Philips Consumer Lifestyle, Philips Healthcare and Philips Lighting.
Regulatory Affairs Manager
Arbetsuppgifter:
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.
Kvalifikationer:
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
Publiceringsdatum2016-11-21Så ansöker duSista dag att ansöka är 0001-01-01
KontaktFöretagPhilips AB
AdressPhilips AB
16485 KISTA
KontorsadressKista Entré, Knarrarnäsgatan 7
Jobbnummer 3171519
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