In this role, you have the opportunity to
Be part of the Regulatory Affairs team in the Zaventem office.
Next to Regulatory Affairs specialists we are also open for people working already at Philips in the Netherlands and are willing to work twice a week from Zaventem. Candidates coming from R&D or Quality within Image Guided Therapy (IGT) who are interested to work in Regulatory Affairs are also welcome to apply.
You are responsible for
-Verifying overview of regulatory status in all countries of EMEAI, LATAM & APAC
-Set up action plan of registration – re registration
-Action plan for new products to be registered
Verification and close interactions with Sale and Marketing
Preparing and submitting product registration files to obtain or to keep marketing approval and import licenses per local Regulatory requirements for CE marked/FDA cleared devices in the countries of IGT-D’s distribution (EMEAI,LATAM & APAC) in order to ensure that IGT_D’s products comply with the regulations
Coordinating documents (CE certifications, Declaration of Conformities, IFU’s) to obtain requested licenses, notarizations, apostille, foreign embassy authentications
Following up on registration process in all regions and filing of all registration documents
Informing dedicated groups of interest and the approval process in QMS and ERP systems
You are a part of
You are part of a motivated team, which enables the commercialization of IGT-D medical devices in compliance with international regulations. We team up to win and we strive to deliver fast and compliant business solutions.
The team consists of 7 people, of which 2 are working in Zaventem, 1 in Costa Rica and 4 in the US.
To succeed in this role, you should have the following skills and experience
Sciences degree – (biomedical, medical of similar degree)
A minimum of 3 years in the Regulatory Affairs in a medical device company is required
Languages: English (written and spoken), knowledge of other languages is a plus point
Proficiency in Microsoft Office Suite, particularly Word and Excel
Software medical devices experience is a plus
APAC/Latin America experience is a plus
Excellent researching skills.
Proven organization skills and multi-tasking abilities.
Open mindedness to new techniques or approaches.
Good communication skills and able to speak in public
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .