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The Position
The Position
Job Title: Senior Regulatory Affairs Officer
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
The Opportunity:
We are looking for a Senior Regulatory Affairs Officer to join our team at Roche Diagnostics. In this position, you will be primarily responsible for handling regulatory affairs in Singapore, which includes planning and executing product registration activities, ensuring regulatory compliance, and establishing strong relationships with local regulatory authorities. Working alongside cross-functional teams, you will contribute your skills as a certified internal auditor as part of the team that leads internal audits and drives continuous quality improvement. You will also assist with the implementation of the Roche Modular Quality Management System and manage post-market surveillance to ensure strict adherence to both internal and external requirements.
As the Senior Regulatory Affairs Officer, you're responsible for:
Drive the end-to-end preparation, review, and submission of product registration dossiers and change notifications to secure approvals from the Health Sciences Authority.
Manage registration databases and internal tracking systems, ensuring accurate and accessible data for all stakeholders.
Partner with global and local teams to align regulatory strategies with strategic business priorities.
Support the preparation and execution of external SS GDPMDS audits, ensuring audit readiness and full compliance.
Manage post-market regulatory activities, including adverse event reporting, field safety corrective actions, and product recalls.
Drive continuous improvement and ensure ongoing compliance with the Roche Modular Quality Management System, while proactively managing risks to deliver safe, high-quality solutions for patients.
Who You Are:
You should ideally possess a bachelor degree in Biomedical Science, Pharmacy or equivalent, preferably with at least 4-5 years of working experience in a similar role.
You have extensive experience with HSA medical device regulations. Experience with National Environment Agency (NEA) regulatory guidelines, such as the Environmental Protection and Management Act (EPMA), is an added advantage.
You are a locally certified internal auditor with experience in conducting internal audits.
You are organized and meticulous, have an eye for detail, possess good analytical and problem-solving skills, as well as excellent verbal and written communication skills.
You should be able to work both independently as well as in a team.
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.