Senior Regulatory Affairs Specialist

Work Flexibility: Hybrid

Help bring innovative medical technologies to patients by driving regulatory excellence across the product lifecycle. In this role, you will shape registration strategies, navigate evolving regulatory landscapes, and ensure compliant, timely access to life‑changing devices. If you thrive in a fast‑moving environment where your expertise directly impacts market success, this is an exciting opportunity to make a meaningful difference.

What you will do

• Prepare, coordinate, and submit regulatory applications to local health authorities to support timely product approvals.
• Compile and complete regulatory submission dossiers including new products, line extensions, amendments, updates, renewals, and change notifications in accordance with applicable regulations and guidance.
• Evaluate products for regulatory classification and determine appropriate submission pathways to enable efficient market access.
• Monitor local regulatory changes, assess impact, and implement required actions to maintain compliance and operational readiness.
• Develop and communicate local submission and registration strategies with design divisions and commercial teams to ensure alignment.
• Review, track, and manage change notifications from divisions and execute required regulatory actions.
• Maintain accurate registration data, license information, and post‑registration activities such as labelling updates and UDI requirements.
• Ensure documentation accuracy by performing detailed reviews and validating completeness of technical files, verification and validation documents, and submission components.
• Participate as a collaborative team member in cross‑functional discussions, audits, and inspections, providing regulatory guidance and timely responses.
• Support internal teams by reviewing marketing collateral for compliance with local regulations and corporate procedures.

What you need

Required Qualifications

• Minimum bachelor’s degree in a scientific, healthcare, engineering, or related field.
• Minimum 3 years relevant regulatory affairs experience in an international or multinational organization.
• Proficiency in spoken and written English and Chinese.
• Experience using regulatory or quality management systems for dossier compilation and license management.
• Experience engaging directly with local health authorities.

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