Regulatory Affairs Executive - with Growth Opportunities

Responsibilities

1. To ensure regulatory compliance of company products and review documentation pertaining to medical device standards of (MDA), European Union (CE), USA (FDA), and other regions.
2. According to the company's plan carry on product registration, system certification, renewal of the certificate obtained, and application for replacement of certificate.
3. Follow up the registration and internal review of registration application information throughout the process and submit the application information to complete the registration application and supplementary application-related work
4. Follow up on the product registration progress, communicate with the government and relevant industry departments on registration matters, coordinate and deal with problems in the registration process, and ensure that registration approval documents are obtained on time.
5. To keep abreast of the updates on local medical device laws, regulations, standards, and guidelines.
6. To maintain and update regulatory files/databases for internal record keeping
7. To involve in third-party/government or customer audits.

Requirements:

1. Candidate must possess at least a Diploma/Advanced/Higher/Graduate Diploma in Biology, Biotechnology, Medical Science, or equivalent.
2. Hands-on regulatory experience in a manufacturing environment with ISO 13485 is preferred.
3. Experience in GMP, HACCP, and regulatory affairs matters related to medical device / disposable products is an
4. Ability to work independently and under pressure
5. Responsible, care, and attention to detail

Benefits

• On-the-job training will be provided
• Medical Benefits
• Incentive Allowance
• Seniority Reward
• Year-end salary adjustment
• Year-End Bonus