Responsibility :-

1. Regulatory Strategy Development

• Develop and execute regulatory strategies for medical device products, ensuring alignment with business objectives and up-to-date regulatory trends.
• Identify regulatory requirements and potential challenges early in the product development process.

2. Submission Management

• Prepare, review, and submit high-quality regulatory documentation for submission to Thai FDA for new product registration and variation.
• Manage timelines and deliverables for regulatory submissions to ensure timely approvals.

3. Compliance Oversight

• Ensure that products comply with all local, national, and international regulations, guidelines, and standards throughout their lifecycle.
• Monitor and interpret changes in regulatory requirements and communicate their impacts to cross-functional teams.

4. Regulatory Agency Interactions

• Serve as the primary point of contact for regulatory agencies, facilitating clear communication and effective problem-solving during interactions.
• Prepare and lead presentations during agency meetings to address inquiries and advance regulatory submissions.

Qualifications :-

• Bachelor’s degree in Life Sciences, Engineering, or a related field
• Minimum of 2 years of experience in regulatory affairs within the medical device industry.
• Comprehensive understanding of global regulatory requirements in Thailand
• Proven track record of successful submissions and approvals for medical device