About Us :

We are a leading In Vitro Diagnostic (IVD) manufacturer committed to delivering high-quality diagnostic solutions worldwide. We are seeking a dedicated and detail-oriented QA Assistant to join our team and support our quality assurance processes to ensure compliance with regulatory requirements and international standards.

Key Responsibilities :

*Regulatory Submissions: Prepare and submit regulatory applications (e.g., IND, NDA, ANDA, BLA, MAAs, 510(k), CE Mark) to agencies such as the FDA, EMA, or other global authorities.

*Compliance: Ensure company products comply with regulations and quality standards throughout the lifecycle (development, approval, marketing, post-market).

*Regulatory Strategy: Collaborate with cross-functional teams (R&D, clinical, quality, manufacturing) to develop regulatory strategies that support product development and approval timelines.

*Communication: Serve as the liaison between the company and regulatory authorities, responding to inquiries and facilitating audits or inspections.

*Documentation: Maintain regulatory files, labeling, and records. Prepare summaries, technical files, and risk assessments.

*Monitoring: Stay up to date with changes in regulatory legislation and guidelines, and advise internal teams on impact and compliance.

*Labeling & Advertising Review: Review and approve product labeling, packaging, and promotional materials for regulatory compliance.

*Post-market Surveillance: Support post-approval product monitoring, adverse event reporting, and regulatory reporting obligations.

Qualifications :

Education: Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related field (Master’s or PhD preferred for advanced roles).

Experience: 1－5+ years in Regulatory Affairs, depending on role level. Familiarity with FDA, EMA, MHRA, PMDA, or global regulatory bodies.

Preferred Qualifications :

_ *Multi-lingual proficiency in both Mandarin Chinese and English at a professional level._

Benefits :

*Competitive salary and benefits package.

*Opportunities for professional growth and development.

*Collaborative and dynamic work environment