Regulatory Affairs, Senior Executive ($3.8K to $4.2K) - Scientific Devices
Recruit Express Pte Ltd| Date Posted: 28-Jun-2019
EA Licence No: 99C4599|EA Personal Registration No: R1333338
Diploma, Bachelor's / Honours
- Participate in the development and lifecycle management of products to ensure compliance with all internal and external requirements for markets such as EU, US, Japan, Korea and APAC.
- Develop, implement and maintain regulatory strategies and regulatory submission plans in order to meet project milestones.
- Prepare, update and maintain technical files/submission dossiers as per applicable SOPs, and liaise with the relevant departments as required.
- Work with project teams to resolve complex project issues by strategically interpreting and clearly communicating regulatory requirements.
- Review and approve documents such as Engineering Change Orders, Design Change Notices and validation reports for scientific merit and regulatory appropriateness for compliance with international regulations and standards.
- Ensure labelling meets all relevant international requirements.
- Conduct regulatory assessments for change controls in line with international regulatory requirements.
- Support internal and external audits as required.
- Contribute to the review and improvement of regulatory processes.
- Min Bachelor’s Degree in science or engineering or any other courses
- Min 2 to 3 years of working experience in Regulatory Affairs field
- Knowledge of Medical and/or Industrial Scientific Device regulations
Salary range: $4K to $5K
MNC (Scientific Devices)
Interested candidates, please forward your resume to [Click Here to Email Your Resume]
Consultant: Huang Jingsheng Kevyn (R1333338)
Recruit Express Pte Ltd (99C4599)
Recruit Express Pte Ltd