Junior Regulatory Affairs & QA Specialist

We are seeking a motivated Junior Regulatory Affairs & QA Specialist to join our team in ensuring compliance and quality across our medical device products. This role will involve supporting regulatory submissions, maintaining QA processes, and ensuring adherence to industry standards. The ideal candidate is detail-oriented, analytical, and has a strong interest in regulatory affairs and quality assurance within the medical device sector.

Key Responsibilities:

• Assist in preparing and submitting regulatory filings and documentation for medical devices.
• Support in maintaining regulatory compliance across all stages of product development and commercialization.
• Participate in internal and external audits to ensure adherence to quality management systems (QMS).
• Assist in developing and implementing QA procedures and policies to meet regulatory requirements.
• Conduct reviews of manufacturing processes, documentation, and labeling to ensure compliance with regulatory standards.
• Collaborate with cross-functional overseas teams including R&D, clinical affairs, and marketing to support regulatory and QA objectives.

Qualifications:

• Diploma or Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related field.
• Previous experience or internship in regulatory affairs or quality assurance within the medical device industry is preferred.
• With or without experience are welcome
• Strong organizational skills with attention to detail and accuracy.
• Excellent written and verbal communication skills.
• Ability to work effectively within a team and independently with minimal supervision.

We regret that only shortlisted candidates will be contacted.