Regulatory Affairs Officer/ Professional
1 week ago
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.
**Job skills required**: Product Development
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