Quality and Regulatory Intern (Medical Device / IVD)

Descrizione del lavoro:

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Program Overview

This 6-month program provides foundational, hands-on exposure to Quality and Regulatory activities within the In Vitro Diagnostics (IVD) industry. The intern will gain a basic understanding of Quality Management System (QMS) principles, local regulatory requirements, and practical experience in pre-market submission documentation and regulatory database management.

Key Responsibilities

The intern will support the Quality and Regulatory team through targeted activities across the product lifecycle, with a focus on compliance and documentation:

1. Regulatory Affairs & Pre-Market Activities:
* Learn about the IVD product lifecycle and review the basic requirements of the Malaysian Medical Device Act (Act 737) and related guidance.
* Assist with compiling pre-market documentation and checking file accuracy for new product registrations.
* Assist with regulatory database maintenance.

2. Basic QMS:
* Gain a general understanding of how to interpret and apply Good Distribution Practice for Medical Devices (GDPMD) requirements in Malaysia.
* Read and review foundational QMS procedures to understand internal compliance requirements.

Learning Outcomes

Upon completion of the program, the intern will be able to:
* Articulate the basic product regulatory lifecycle and the role of RA.
* Demonstrate hands-on practical experience in regulatory database maintenance and record management.
* Understand the core sections of the QMS and the application of GDPMD requirements.
* Develop professional communication skills through presentations and team interactions.

Requirements

* Currently enrolled in a relevant degree program (e.g., Engineering, Science, Pharmacy, or equivalent) at a recognized Malaysian university.
* Strong attention to detail and a methodical approach to data and documentation.
* Proficiency in Microsoft Office (Word, Excel) is required for record keeping and analysis.
* Eagerness to learn, strong self-motivation, and effective communication skills.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer