Senior Regulatory Affairs Specialist
medtronic
Senior Regulatory Affairs Specialist
roche· 6082 Roche Dia Hong Kong Ltd
About this role
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
Roche Diagnostics
Job Purpose
Serves as a strategic business partner to commercial and operational teams, driving regulatory market access and registration excellence across Hong Kong and Macau. Engages proactively with health authorities and industry associations to shape favorable regulatory pathways, ensuring Roche Diagnostics maintains its IVD market leadership while navigating evolving regulatory landscapes.
Responsibility & Accountability
Regulatory Affairs:
Regulatory Strategy & Market Access: Formulate and execute comprehensive regulatory strategies for Hong Kong and Macau to secure timely product registrations, approvals, and lifecycle maintenance aligned with organizational goals.
External Engagement & Policy Intelligence: Monitor, interpret, and assess regulatory environment changes; maintain proactive dialogue with local health authorities and industry associations to support favorable regulatory frameworks and review pathways.
Subject matter expertise in regulatory submission: Lead the designated product portfolios, work closely with the RA and cross teams to provide regulatory guidance to resolve complex submission and compliance challenges.
Compliance & Quality Assurance: Ensure local operations adhere to global quality standards, IVD/medical device regulations, and local SOPs; oversee quality management tasks, audit readiness, promotional material reviews, and internal compliance training.
Cross-Functional Partnership: Collaborate closely with local commercial, marketing, quality, regional, and global stakeholders to ensure regulatory alignment throughout the product lifecycle and enhance cross-team operational efficiency.
Requirements:
Education:
B.S. degree in Biomedical Science, Life Sciences, or related field.
Experience:
4-5 years of health-related regulatory experience
Team management experience preferred
Competency:
Strong understanding of regulatory environments and requirements of HK, Macau, China, EU, and US authorities.
In-depth knowledge of Medical Device and IVD regulations, international, quality standards (e.g. ISOs) & guidelines
Strategic thinking with the ability to simplify complexity and challenge the status quo
Business acumen & communication: Strong cross-functional communication skills to translate complex regulatory requirements into commercial solutions.
Digital & process proficiency: Hands-on capability with digital tools and automation to establish tracking systems and dashboards.
Policy Advocacy: Strong aptitude for external advocacy, policy shaping, and simplifying complex regulatory issues.
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.
Frequently Asked Questions
Is the salary disclosed for the Senior Regulatory Affairs Specialist position at roche?
The salary for this Senior Regulatory Affairs Specialist role at roche is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Senior Regulatory Affairs Specialist position at roche located?
This Senior Regulatory Affairs Specialist role at roche is based in Hong Kong. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Senior Regulatory Affairs Specialist role at roche full-time or part-time?
This is listed as a Full time position. It is posted as a Senior Regulatory Affairs Specialist role in the 6082 Roche Dia Hong Kong Ltd department at roche.
Which team or department does the Senior Regulatory Affairs Specialist at roche belong to?
This Senior Regulatory Affairs Specialist position is part of the 6082 Roche Dia Hong Kong Ltd department at roche. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Senior Regulatory Affairs Specialist position at roche?
Click the "Apply Now" button on this page. You will be redirected to roche's official application portal hosted on workday where you can submit your application directly.
When was the Senior Regulatory Affairs Specialist job at roche posted?
This Senior Regulatory Affairs Specialist position at roche was posted on Aug 21, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Regulatory Affairs Specialist
roche
You'll be redirected to roche's official application page on Workday.