Regulatory Affairs Specialist

Job Title

Job Description

Type: Junior Role
Time: 40 hours/week

Be part of the Business Image Guided Therapy Devices International. You will be able to work in a large and complex organization. Therefore, the job at any level demands knowledge, experience and understanding of the organization, the often conflicting interests at play and the many business processes and disciplines that are managed by the Manager.

You are responsible for

The Regulatory Affairs (RA) Coordinator is experienced in all standard RA Clerical tasks. They work in a very large and complex organization where substantial interests are at stake, the effects of which affect the entire Philips company or a large proportion of it. Therefore, the job at any level demands knowledge, experience and understanding of the organization, the often conflicting interests at play and the many business processes and disciplines that are managed by the Manager.

In addition, in this category of jobs the Regulatory Affairs (RA) Coordinator has to make decisions without consulting others and is held responsible for these decisions afterwards. In view of the conflicting interests, the nature of the contacts is very critical. A further aspect is the need to be able to think ahead and to take action in such a way as to enable decision-making processes and priorities, for example, to be controlled more effectively by the Department Heads.

Provide administrative support to the Head of Regulatory Affairs (RA) including (but not limited to) the following responsibilities:

• Tracking and trending departmental objectives, KPIs, RA deliverables required for execution of RA Strategies for Continuous Market access and compliance in all Regions.

• Developing Procedures to support a virtual team spread across geographies.

• Performing entirely independently, delivering all RA documents with the required notarizations/legalizations/Apostilles/Cover letters which involve a high level of responsibility and understanding of International regulations; it also includes the tracking tasks and deadlines, both for your manager and for his/her reports and colleagues in the Business Units (BU) and in the countries (Philips colleagues and/or Distributors).

• Providing administrative support for preparations of meetings,;

• Maintain website/SharePoint content

• Manage calendars and schedule proactively

• Manage Daily Management, Departmental Objectives, departmental reports and Newsletters among other RA projects as assigned (including developing minutes, tracking actions, status reporting)

• Organize (and host) meetings, events, video conferences, Web casts

• Domestic and global travel arrangements and process related expenses

• Knowledge resource on Philips policies

• Deal with sensitive, complex and highly confidential information

• Serve as a contact to employees or other stakeholders inside and outside the organization

• Conduct various analytical projects and preparations for Senior Management Meetings

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, we are looking for a new colleague to join us in the Zaventem office location.

To succeed in this role, you should have the following skills and experience

• Bachelor or Master Degree in Business Administration, Management, Business Economics, Engineering, Political Sciences, International Relations, Law, or related studies

• Affinity for Quality and Regulatory Affairs

• Problem solving and proactive mindset

• MS Office expertise with advanced skills in Excel, PowerPoint, and, SharePoint

• Is organized, flexible, motivated, analytical, creative, and can prioritize workload

• Strong ability to develop and maintain cross functional relationships

• Fluent in English, Dutch or French are a plus

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:

• A market conform salary

• 25 Days of leave and the possibility to purchase up to 20 extra days off annually

• A variable bonus based on both Philips results and personal performance

• Extensive set of tools to drive your career, such as a personal development budget, free training and coaching

• Solid company pension scheme and attractive collective health insurance package

• Opportunity to buy Philips shares and products with discount

• Healthy work-life balance

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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