Medical Device : Regulatory Affairs Specilaist / Manager (Class II&III)

【Client Description】

• Multinational or local medical device company with a portfolio of Class II and Class III products and active expansion into global markets.

• Established capabilities in product development, manufacturing, and regulatory compliance.

【Candidate Profile】

• Minimum 2 years of experience in medical device regulatory affairs, with hands-on experience in Class II or Class III devices.

• Strong knowledge of Taiwan TFDA regulatory requirements and submission processes.

• Familiarity with international regulatory frameworks, including U.S. Food and Drug Administration 510(k) and EU MDR.

• Experience in preparing Technical Documentation, STED, or equivalent regulatory dossiers.

• Understanding of Quality Management Systems, particularly ISO 13485.

• Strong technical writing and documentation skills, with the ability to independently prepare and review regulatory submissions.

• Effective cross-functional communication skills.

• Proficiency in English, including reading and writing regulatory and technical documents.

【Responsibilities】

• Manage product registration, renewal, and variation submissions for Class II and Class III medical devices in Taiwan (TFDA), including preparation of Technical Documentation and STED dossiers, and response to authority inquiries.

• Execute import regulatory processes, including product registration, customs clearance coordination, and compliance review of labeling and Instructions for Use (IFU).

• Support export regulatory strategies and submission documentation for global markets, including the United States, European Union, and Asia-Pacific regions.

• Develop and maintain global regulatory pathways, including regulatory classification, gap analysis, and timeline management across multiple jurisdictions.

• Maintain regulatory dossiers and documentation control in compliance with QMS requirements (ISO 13485), including change control and document versioning.

• Collaborate cross-functionally with R&D, QA, manufacturing, and marketing to ensure regulatory compliance throughout the product lifecycle, including design control.

• Act as the primary liaison with regulatory authorities and notified bodies, handling communications, deficiency responses, and submission follow-ups.

• Monitor and assess updates in global medical device regulations and standards, and evaluate their impact on company products and regulatory strategy.