Senior Regulatory Affairs Specialist

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.