Regulatory Affairs Specialist

Job Title

Regulatory Affairs Specialist

Job Description

In this role, you have the opportunity to

Be part of the Regulatory Affairs team in the Zaventem office. You will work in an international setting with global stakeholders working for medical devices within IGT-D (IGT-devices).

You are responsible for

• Setting up and maintaining all regulatory files
• Verifying overview of regulatory status in all countries of EMEAI, LATAM & APAC
• Set up action plan of registration – re registration
• Verification with Sales and Marketing team
• 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 regulation
• 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)
• 3-5 years in the Regulatory Affairs in a medical device company is required
• Preference for someone who has experience working with RA in countries EMEAI, LATAM & APAC
• Experience in a corporate environment and effectively work across departments
• Proven organization skills and multi-tasking abilities
• Open mindedness to new techniques or approaches
• Software medical devices experience is a plus
• Fluent in English
• Excellent 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. 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 on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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