Regulatory Affairs Specialist II

• Compile and review technical documentation for product registrations in Southeast Asia (SEA) countries.
• Review and edit dossiers to meet countries requirements, ensuring the accuracy and consistency of information.
• Support SEA countries channel partners in complying strictly with local regulations.
• Collaborate with internal and external partners to address regulatory obstacles.
• Respond to questions related to product registration and change notification from regulatory agencies.
• Keep track of license validity in SEA countries and ensure licenses are renewed in a timely manner.
• Stay on top of regulatory requirements and developments, monitor and work with internal/external collaborators to ensure seamless product supply.
• Provide input for regulatory change assessments to determine the impact on registrations.
• Handle Adverse Events and Field Safety Corrective Action reporting in countries of responsibility.
• Assist in QMS maintenance and internal/external audits.
• Support GMP certificate renewals in countries where applicable.

Requirements

• Bachelor's degree or equivalent experience in a relevant field.
• 2 - 5 years in regulatory affairs roles in medical devices or in-vitro diagnostics industry.
• Outstanding organizational skills with the ability to manage multiple tasks.
• Strong communication and interpersonal skills.
• Ability to adapt and succeed in a fast-paced environment.
• Dedication to excellence and a high level of integrity.