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
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