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Skills:

Contracts, Legal, Compliance, English

Job type:

Full-time

• Draft, review, and negotiate contracts and legal documents in Thai, local languages, and English, ensuring alignment with business operations and legal requirements.
• Provide legal advice and consultation on various business activities, including advertising and product labeling.
• Ensure compliance with laws governing financial transactions, such as long-term loans and capital increases for subsidiaries.
• Conduct legal research, summarize findings, and report updates to management.
• Provide notarial services and legal document certification.
• Oversee the preparation and submission of corporate filings, such as board resolutions and changes in company structure.
• Manage business licenses and coordinate with external legal firms for necessary approvals.
• Liaise with subsidiaries and external law firms to ensure legal procedures are completed in a timely manner.
• Prepare reports and provide updates on relevant legal matters to senior management.
• Develop internal processes and documentation systems for better legal oversight.
• Perform other duties as assigned by management.
• Bachelor s or Master s Degree in Law or equivalent.
• Minimum of 8 years of relevant legal experience.
• Strong proficiency in Thai and English (both written and verbal).
• In-depth knowledge of business laws, international trade regulations, and stock exchange rules.
• Understanding of corporate governance and organizational projects.
• High level of responsibility and ability to learn new legal frameworks.
• Strong decision-making and problem-solving skills.
• Leadership ability to manage and guide the legal team.

Skills:

Product Development

Job type:

Full-time

• 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.
• 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.
• 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.
• 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.
• 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.