Regulatory Affairs Specialist

About Tianyi Medical

Tianyi Medical is a leading manufacturer of Class III medical devices and medical consumables with more than 30 years of experience in the medical device industry.

Tianyi Medical (Thailand) has established its manufacturing facility in Rayong, Thailand to support its international business expansion. The company focuses on the R&D, manufacturing, and global distribution of medical consumables and devices, including blood purification products, infusion devices, nutrition systems, rehabilitation equipment, and medical hygiene products.

The company operates under international quality and regulatory requirements, including ISO 13485, with products serving markets in China and overseas markets across Asia, Europe, America, and South America.

About the Role

We are looking for an experienced Regulatory Affairs Specialist to join our team and support regulatory activities for medical devices in Thailand and international markets.

This role will focus on Thailand FDA registration, ASEAN regulatory submissions, and coordination of US FDA activities, ensuring regulatory compliance throughout the product lifecycle.

Key Responsibilities

• Manage Thailand FDA (TFDA) product registration, notification, licensing, renewal, and variation submissions.
• Act as the company's registered pharmacist and regulatory contact in Thailand.
• Prepare and review regulatory dossiers, technical documentation, labeling, IFU, certificates, and supporting documents.
• Support product registration and regulatory submissions across Southeast Asian (SEA) markets.
• Prepare and coordinate regulatory documentation based on ASEAN CSDT requirements.
• Coordinate and support US FDA regulatory activities, including applicable pathways such as 510(k), De Novo, PMA, eSTAR, and Q-Submission.
• Respond to regulatory authority questions and requests for additional information.
• Monitor regulatory changes and assess their impact on products and registrations.
• Maintain regulatory licenses, registrations, submission records, and regulatory timelines.
• Collaborate with R&D, QA, QC, Production, PMO, and other relevant departments.

Qualifications

• Bachelor's degree or higher in Pharmacy.
• Active professional pharmacist license issued by the Pharmacy Council of Thailand.
• Minimum 3 years of experience in Regulatory Affairs, preferably in the medical device or pharmaceutical industry.
• Hands-on experience with Thailand FDA product registration.
• Good knowledge of medical device regulatory requirements and regulatory documentation.
• Knowledge or experience in ASEAN / CSDT regulatory requirements is preferred.
• Experience with US FDA regulatory submissions is an advantage.
• Good command of Thai and English, both written and spoken.
• Strong communication, coordination, analytical, and problem-solving skills.
• Detail-oriented and able to manage multiple regulatory activities and deadlines.

Preferred Experience

• Experience in a medical device manufacturing environment.
• Experience with ASEAN medical device registration.
• Experience supporting US FDA 510(k), eSTAR, De Novo, or PMA submissions.
• Knowledge of ISO 13485 and medical device Quality Management Systems.

Working Conditions

• Working Hours: 08:00 AM – 05:00 PM
• Working Days: Monday – Friday + Saturday every other week
• Working Schedule: Alternate Saturday working schedule
• Work Location: Amata City Industrial Estate, Rayong, Thailand
• Salary: Negotiable, based on qualifications and relevant experience

Why Join Tianyi Medical

• Join an international medical device manufacturing company with 30+ years of industry experience.
• Gain exposure to Thailand, ASEAN, and US FDA regulatory affairs.
• Work in an international and cross-functional environment.
• Opportunity to develop your career in Medical Device Regulatory Affairs.
• Be part of a growing manufacturing operation in Thailand.