RA Support Assistant

Regulatory Affairs Manager

Interprets federal/state/international regulations as they apply to our products, processes, and/or procedures advises on the impact of regulations, devises strategies for compliance, and liaises with regulatory bodies. Investigate and resolve compliance problems, questions, and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. Executes appropriately on product recalls. Respond to regulatory agency inquiries. Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.

Key Responsibilities:

• Gathering and preparing documents for new application submission in the medical device process and including amendment documents for submission after receiving TFDA feedback by the deadline. (Pre-Submission and E-Submission)
• Supporting to confirm label process with TFDA system.
• Gathering and preparing documents for diagnosis of medical devices. (Products not medical devices in Thailand such as laboratory products etc.)
• Gathering information on importing and selling medical devices under the importer and making a report to the TFDA.
• Gathering and preparation of documents for permission to advertise with TFDA for support sales and marketing events.
• Gathering and preparing documents for amendment request application with TFDA when information changes and meets the requirements that the TFDA is allowed to submit for amendments such as Software.
• Supporting every renewal of the license of the master document. or new regulations of the TFDA.
• Supporting and helping RA administration in general tasks.

Job Requirements:

Qualifications:

• Bachelor's degree or equivalent

Experience:

• Preferably minimum 1 year of experience in regulatory affairs
• Experience in medical device registration with a Thai FDA company is preferred; IVD, pharmaceutical, or biologics would also be considered

Personal skills/Attributes:

• Intermediate of English skill
• A good team player
• Hands-on and Detailed
• Good communication and interpersonal skills
• Demonstrated ability to deliver assignments on time
• Proficient in Microsoft Office and Adobe Acrobat

Operating Company: Kerr

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