Job Description
More than just a recruitment company. At PRTR, we have been a part of our customer's success for 30 years as their total HR solutions partner. With 550 dedicated professionals and over 15,000 outsourced staff, we will continue to carry out our mission to develop a better career, a better life, and a better society, and thrive to become the No.1 people solutions organization in Southeast Asia.
Main Responsibilities
- Organization wise: Designing, monitoring, and implementing the E2E flow as well as the company’s role and responsibilities in compliant with Thailand Medical Devices Regulations.
- Product registration wise: Reviewing and completing the submission package in CSDT (class IV medical devices), submitting to the Thai FDA portal, providing answers to Thai FDA questions, and getting accelerated approval of the product.
- Tailored support with outcome-based planning.
- Strategic actions through complex regulatory environments.
- Operational effectiveness to meet Thai FDA practices.
- Any other actions related to Medical device implementations.
Qualifications / Screening Criteria
- Bachelor's Degree related field.
- Experts in Thailand's Medical Devices requirement with more than 10 years of work experience and the latest regulatory insights.
- An accelerated approval of a product (medical device class IV).
- Effective communication in English.
- Responsible Be flexible in work and able to manage your time.
- Can work in the office 3 days per week in a temporary capacity, but you will receive a monthly salary.
- A company license as an authorized importer for Medical Devices.
- Secure license to operate in compliance with Medical Devices Regulations.