Quality & Regulatory Intern

<p>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.</p><h3></h3><p></p><h3>The Position</h3><p><span><b>Role Purpose:</b></span></p><p></p><p><span>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.</span></p><p></p><p><span><b>In this role, you will support the Quality and Regulatory team through targeted activities across the product lifecycle, with a focus on compliance and documentation:</b></span></p><p></p><p><span><b>1. Regulatory Affairs &amp; Pre-Market Activities:</b></span></p><ul><li><p><span>Learn about the IVD product lifecycle and review the basic requirements of the Malaysian Medical Device Act (Act 737) and related guidance.</span></p></li><li><p><span>Assist with compiling pre-market documentation and checking file accuracy for new product registrations.</span></p></li><li><p><span>Assist with regulatory database maintenance.</span></p></li></ul><p></p><p><span><b>2. Basic QMS:</b></span></p><ul><li><p><span>Gain a general understanding of how to interpret and apply Good Distribution Practice for Medical Devices (GDPMD) requirements in Malaysia.</span></p></li><li><p><span>Read and review foundational QMS procedures to understand internal compliance requirements.</span></p></li></ul><p></p><p><span><span>Any other tasks or projects as assigned from time to time.</span></span></p><p></p><p><span><span><b>Who you are: </b></span></span></p><p><span><span>You are someone who are/have:</span></span></p><ul><li><p><span><span>Highly motivated and detail-oriented individual.. </span></span></p></li><li><p><span><span>Possess strong organizational and analytical abilities.</span></span></p></li><li><p><span><span>Core requirements include meticulous attention to data, a methodical approach to documentation.</span></span></p></li><li><p><span><span>Eagerness to learn complex regulatory standards</span></span></p></li><li><p><span><span>Self-motivation to execute tasks accurately, supported by effective communication skills.</span></span></p></li></ul><p></p><p><span><b>Qualification and Experience:</b></span></p><p><span><b>Essential:</b></span></p><ul><li><p><span>Currently enrolled in a relevant technical degree (Biomedical Science, Pharmaceutical Science, Pharmacy, etc.) at a recognized Malaysian university.</span></p></li><li><p><span>Proficiency in standard office software (e.g. Word, Excel).</span></p></li></ul><p><b> </b></p><p><b> </b></p><p></p><h3>Who we are</h3><p style="text-align:left">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.</p><p style="text-align:left"><br />Let’s build a healthier future, together.</p><p style="text-align:inherit"></p><p style="text-align:left"><b>Roche is an Equal Opportunity Employer.</b></p>