Job Title

Internship: Regulatory Affairs and Compliance in Medical Devices

Job Description

In this role, you have the opportunity to

Contribute a high growth business that will help improve the lives of millions contributing with a global leader in Health Technology.

You are responsible for

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  Technical documentation verification - work with team members to review and recommend changes in technical documentation for achieving and maintaining its compliance to pertinent regulations and standards. Follow-up with verification of remediation activities to ensure completion of remediation.

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  Work together with cross-functional teams to develop technical documentations / other regulatory submissions while ensuring that the information is accurate and complete as per applicable requirements.

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  Support in compiling local in-country documentation and follow-up with in-country regulatory authority for successfully registering products and obtaining marketing authorization for medical devices.

• 
  Support in building Philips databases with registration and / or technical documentation remediation status overview. Verify the accuracy of registrations and life-cycle maintenance in external regulatory databases.

• 
  Work together with team members for regulatory intelligence and to research regulatory topics for developing accurate responses to inquiries from different internal Philips and external stakeholders.

• 
  Work together with team members to develop Quality Management tools for the functioning of a new team.

You are a part of

The Regulatory Affairs & Compliance Team, Philips Medical Systems Nederland B.V. Best, The Netherlands, and report to the Head of Regulatory Affairs & Compliance Team. You will be located in the region of Lisbon and affiliated to the Philips office in Lisbon (Portugal); and will also support the local Regulatory Affairs team if and when needed.

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

• 
  Finishing studies or recently graduated (no more than 1 year) from University Master?s degree (M.Sc.) in Biomedical Engineering, Health Engineering, other relevant Engineering courses, Medical Science, Health Science, Pharmaceutical Science.

• 
  Excellent analytical thinking to be able to interpret large amounts of information and synthesize insights is a must.

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  Good Verbal and written communication skills with excellent fluency in English and Portuguese is a must. Fluency in other European languages is an advantage.

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  Internships / University Courses / University Thesis completed in - Technical Documentation / Medical Device Regulatory Affairs / Quality Management System. This is a definite advantage not a must.

• 
  Working knowledge of appropriate global medical device regulations, like European Medical Device Regulation (2017/745), and standards such as ISO 13485, ISO 14971, ISO 10993, IEC62304/62366/60601 etc., is an advantage, but not a must.

In return, we offer you

Insights into the Research & Development, Manufacture and Regulatory Affairs of a wide range of Medical Devices of low, moderate and high risk. Open career development possibilities within Philips or elsewhere in Regulatory Affairs of Medical Devices.

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 2.5 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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