Regulatory Affairs Executive (Entry Level)

Responsibilities

• Dossier Preparation & Submissions: Compile and organize registration documentation for local (MDA) and international regulatory authorities.
• Technical Documentation: Prepare and maintain Instructions for Use (IFUs), product labeling, packaging information, and customer-requested regulatory documents.
• Audit & Compliance Support: Assist with QMS and GDPMD compliance activities, including document control and follow-up on audit findings.
• Regulatory Tracking: Monitor local and global medical device regulations to ensure company documentation remains compliant with current standards.

Requirements

• Bachelor’s Degree in Science (Biotechnology, Life Sciences, Pharmacy, Biomedical Science, or related field).
• Fresh university graduates are welcome to apply.
• Strong written and verbal communication skills with an eye for technical writing and precise documentation.
• Highly organized, detail-oriented, and eager to learn regulatory frameworks.