Responsibilities:
* Follow up RA registration plan and monitor registration schedule.
* Support all Registration projects in APAC regions.
* Support and coordinate registration material preparation for new products launching into market.
* Provide RA Assessment & RA strategies according to the business.
* Support and compile recognized standards are compliance with regulations in APAC
* Support regulatory and review on the relevant documents and reports.
* Support the information of related law or regulation and advice to the company and the plant management when needed,
* Support documents related to product registration to customers.
* Certificate issuance (renewal, change notification), etc.
* Support resolved during registration.
- Technical documents
- Regulatory documents
Qualifications:
- At Least more than 2 years’ Medical device QARA experience
- Familiar with medical device registration and approval procedures, familiar with medical device industry related laws, regulations and policies
- Have knowledge about ISO 13485
- Ability to work cross--functionally, good teamwork; detail-oriented