Job Description
- To coordinates the process of product registration and market access approval in the designated countries including providing all required documents and certificates within the specified timeframe proactively to complete product registration.
- To provide advice to internal and external teams in interpreting relevant guidance documents and standards.
- To contact local authority and organization for both regulatory problems solving and obtain updated information on current and developing regulations.
- To review and approve documents to support Post Market Change notification (including labelling changes) to comply with international regulations and standards.
- To remain up to date on regulations and communicate any key changes to stakeholders in the broader organization.
- To provide training when necessary and assist with the development of the respective countries’ Regulatory Affairs infrastructure to facilitate greater speed to market.
- To take charge of QA (complaint reporting etc) for all subsidiaries.
Qualification
- Degree/ Diploma in Biomedical engineering or science or QA/RA related field
- Minimum progressive 3 years of QA/RA working experience in medical device manufacturing industry
Interested candidate, please email to [email protected]
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
