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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.

Job type:

Full-time

• Head of Section / Senior Officer / Officer - Investigation (Internal Affairs).
• Establish guidelines and processes for investigation and inquiry into financial crimes and fraud.
• Investigate, inquire, analyze, and summarize findings of fraudulent activities to determine the causes and origins.
• Examine and gather documentary evidence, facts, financial transaction records, and visual evidence related to financial crimes and fraud from the bank's work systems and relevant departments, including the acquisition of confidential information.
• Extend the scope of investigation to customer card and account transactions, merchant payments, or criminal groups to identify connections with other sources, aiming to reduce risk and prevent damage from criminal groups.
• Temporarily suspend card or account transactions to mitigate risks and damages to the bank or customers, in accordance with established criteria and the outcomes of investigations and inquiries.
• Summarize the findings of investigations, including causes, facts, the process of the actions, and individuals involved in the fraud.
• Present the summarized factual findings to the working committee for considering resolutions for customer losses in cases of external fraud, or to executives for determining resolutions for defrauded customers or affected parties.
• Collaborate with relevant departments within the bank, member banks in the Anti-Fraud and Examination Club (under the Thai Bankers' Association), Visa Risk Management, and the Royal Thai Police.
• Collect information on fraudulent activities and file complaints against perpetrators when the bank is the injured party, and/or act as the bank's authorized representative in filing criminal and related civil lawsuits against those who commit fraud against the bank.
• Coordinate the handover of documents, evidence, facts, financial transaction records, and visual evidence related to financial crimes and fraud to investigative police officers, or as requested by the Royal Thai Police, to provide information on the damages caused by perpetrators and collaborate with law enforcement to find ways to prosecute, prevent, and suppress financial fraud.
• Assist customers or affected third parties who have suffered damages, or relevant government agencies.
• Plan and provide training and knowledge on fraud risks, methods, trends, as well as prevention and control measures, to relevant departments to reduce/prevent future losses.
• Prepare investigation reports based on received notifications, detailing damages and the recovery of funds for the bank and customers, to present trends of groups or individuals likely to commit fraud against the bank, and submit monthly reports to internal work units for compiling the department's monthly summary report.
• Bachelor's degree or higher in Law, Legal Studies, or a related field.
• Experience in legal work, preparing case files for filing complaints, accusations, and lawsuits, or experience in court proceedings.
• Strong analytical, investigative, and fact-finding skills, as well as the ability to manage and retrieve information from databases and various documents.
• Proficiency in basic Microsoft Office programs such as Word, Excel, and PowerPoint.
• Ability to travel to work in other provinces.
• Ability to work on holidays/overtime during urgent situations.
• Strong management, analytical, and problem-solving skills for immediate issues.
• Good negotiation, communication, and interpersonal skills, with the ability to work effectively in a team.
• Proactive with a willingness to continuously learn and develop oneself.
• Good command of the English language.
• Skills and abilities related to interviewing witnesses according to the Royal Thai Police's regulations.
• Knowledge and understanding of internal branch banking systems and accounting systems.
• Familiarity with the banking business, various products, and services of the bank.
• (*Fresh graduates are welcome to apply.).
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