Job Description

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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.

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 (Masters 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

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Medical Equipment Manufacturing

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Job Tags

Full time, Local area, Worldwide, Relocation package, Night shift, Day shift,

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