Job Responsibilities:
- Researches and keeps updated on outside medical regulations, updates processes where necessary, and communicates updates/changes affecting the quality system to concerned parties.
- Identifies and coordinates the submission of all pertinent information for new medical device product approval and monitors the regulatory status of new product developments.
- Participates in the development, execution and approval of process and software validations and ensures that validation results are in compliance with customer and FDA requirements.
Qualifications:
- Bachelor's Degree in Engineering or Science
- Knowledge of regulatory requirements for Medical devices and ISO 13485 Requirement is a major advantage
- Minimum of 0-5 years of working experience in Medical product
- Very good command of written and spoken English. TOEIC > 600 would be an advantage
The Human Resources Department
Benchmark Electronics (Thailand) Public Company Limited
Ayudhaya Address : 94 Moo 1, Hi Tech Industrial Estate, Banlane, Bang Pa-In, Ayudhaya 13160
Tel. (035) 276-300 ext. 2010 Fax : ( 035 ) 276-399
Website: www.bench.com
