Senior Regulatory Affairs Specialist

在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。

职位

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.

我们是谁

打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。

让我们一起，构建更健康的未来。

罗氏提供平等的职业发展机会。