Our client is a medical device company.
Key Responsibilities
- Prepare, provide, and submit regulatory documents for both new and renewal registrations, ensuring compliance with all applicable requirements.
- Coordinate the submission process and diligently follow up to ensure that all registrations and regulatory obligations are met within the designated timelines.
- Stay vigilant in monitoring and staying updated with the latest regulatory changes. Assess the risks and opportunities associated with any alterations in regulations.
- Continuously adapt and enhance workflow processes to facilitate efficient and effective problem-solving.
- Take the lead in providing regulatory training and consulting services to both internal and external stakeholders.
- Play a pivotal role as a key user in implementing quality and regulatory databases, ensuring adherence to established procedures and guidelines.
Requirements
- a RA specialist with 3 to 10 years' experience working in the medical device industry.
- Understanding of quality management systems
- Ability to manage and prioritize multiple projects and deadlines.
- A commitment to staying updated on changes in medical device regulations and industry best practices.
- Proficient in both written and spoken English.
If you are interested, please submit your most recent resume in English (preferably in Word) by clicking the 'APPLY' or send it to pacita.phaohusara@jac-recruitment.com
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