Internship: Regulatory Affairs

2 semanas atrás

Lisboa, Portugal Philips Tempo inteiro

**Job Title**: Internship: Regulatory Affairs & Compliance Intern

**Location**:Lisbon

**Working time**:39 hours/week

**Start date**:as soon as possible

**1 year internship contract**

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

**In this role, you have the opportunity to make life better**

A technical documentation is proof that a medical device complies with the requirements set down by the relevant legislations of the region / countries where the device is marketed and are submitted to regulatory authorities for getting approval for market access. Technical documentation is also evidence that safe and effective medical devices designed, manufactured, placed on the markets, available and used by patients and healthcare professionals. The Clinical and Post Market documentations (part of technical documentation) evaluate the clinical and post market data from markets to continuously ensure no new hazards have emerged and that the clinical benefits of the device outweigh the risks to patients. Data collected so might feedback into new design or manufacturing corrections or improvements and needs to be accurately captured in the technical documentation. In doing so RACT (Regulatory Affairs and Compliance Team) has the unique opportunity of working with a very diverse portfolio of medical devices from different manufacturers located across the globe.

**You are responsible for**
- Review local regulations and standards applicable in different geographies.
- Assessment of technical documentations on a wide range of medical devices for compliance to regulations and standards. Providing critical feedback to Philips manufacturers and follow-up with them to ensure that the devices have been designed to be safe and effective, and meet all required legislations and state of the art standards, both prior to its launch and thereafter in use.
- Support in the registration process of Philips medical devices with local authorities in different countries.
- Support in building databases with completion and review.

**You are a part of**

You are part of the Regulatory Affairs and Compliance Team, Philips Medical Systems Nederland B.V. Best, The Netherlands. You report to and work under the direction of the Head of Regulatory Affairs & Compliance Team. While you will work remotely with this team, you will be located in the region of Lisbon and be affiliated to the Philips office in Lisbon (Portugal); and will also support the local Regulatory Affairs team when needed.

**To succeed in this role, you’ll need a customer-first attitude and the following**
- A research minded student or graduate having a profile in Master of Science degree at a Technical University.
- Of special interest are students of Biomedical Engineering or any scientific discipline or Engineering degree.
- A critical and analytical thinker; a keen and good learner.
- A perseverant and proactive team-player who can work both independently and within the team.
- Previous internship in either regulatory affairs or clinical affairs in a medical device, or pharmaceutical or cosmetics, or other fields - this is an advantage.
- Proficiency in local language and English is a must. If you are skilled in Spanish that is an advantage.
- Above all - Passionate about healthcare with a strong motivation to bring safe and effective medical devices to patients.

**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 / Research & Development of Medical Devices.

**How we work at Philips**

Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home - for our hybrid roles.

Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

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