东莞招聘

Regulatory Affairs Specialist (技术法规专员)

Position Objective
1. The person shall have the ability to manage and submit product registrations and change notifications for CFDA for medical LOB. The role will also require correspondence with Government authorities’ and labs in handling technical issues in Pall’s interest.
2. The incumbent shall also manage post-market issues and responsibilities as required by regulations and independently report to RA Manager Asia on regulatory compliance issues in China.
3. The incumbent shall also be responsible for all duties required by the CFDA as a legal representative in China.
Main Responsibility:
1. Draft and submit technical standards (items 1 to 7 75%)
2. Manage and oversee local RA testing at test centers
3. Preparation and translation of registration documents
4. Liase with consultants when utilised
5. Review of testing evaluation data
6. Submission of product registrations
7. Liase and discuss RA issues with reviews
8. Attend SFDA industrial meetings and reviews (Items 8 to 11 15%)
9. Postmarket responsibilities (Adverse events determination and reporting, recall handling)
10. Legal rep for Medical business licence
11. Submission of business licences
12. Label review and preparation (Item 12 10%)

Qualifications Needed:
1. Degree in Biomedical Science/Engineering
2. 3-5 years in Regulatory affairs
3. Written and spoken Chinese and English with the ability to handle translations between both languages
4. The position requires a position who can learn fast and work independently
5. Strong interpersonal skills
6. Resourceful, meticulous and organized; paying attention to details
7. Position also requires a person who can understand and interpret technical and scientific reports related to Medical terms.
8. Some degree of regulatory strategy planning will be required