Avensys Consulting Pte Ltd
Avensys is a leader in providing technology enabled business solutions and services. Since inception, Avensys has helped clients use IT more efficiently to improve their operations and profitability, focus on core competencies and achieve business results such as increased agility, innovation and profitable growth. Our in-depth technical knowledge coupled with industry experience and our unique methodologies enable us to successfully deliver and meet our customer’s expectations.
Regulatory Affairs Associate/Specialist
jobsDB Ref. JSG400003003153260
EA License No 12C5759
Contract : 12 months and renewable
Location :Jurong East
1. The Regulatory Affairs Associate will be responsibility for regulatory aspects of the assigned product portfolio/s
2. Preparation of submissions to the local health authority for new products i.e. medical devices.
3. Liaise and establish cooperative relationships with local stakeholders to ensure understanding of regulatory requirements in Singapore and request the documentation required for registration submissions
4. Build constructive relationships with the local health authority by compiling and submitting high quality submissions and providing prompt responses to questions
5. Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio
6. Work closely with Regional Planning Team, RDC operation and RDC Finance to make sure new product in RDC to be registered under Special Access Scheme (for re-Export).
7. Monitor Import forecast in GN28 registration and the forecast consumption to initiate registration update with revised forecast.
8. Contribute to continuous review and improvement of processes within the RA department and RDC Team to ensure consistent, efficient and effective practices across the team
9. Contribute to RA and RDC Team meetings to learn from colleagues, share experiences and best practice
• Bachelor's degree or equivalent in Science or related discipline;
• Familiarity with regulatory requirements in Singapore and Medical Device product
• Previous experience in preparing documents for health authority submissions is desirable;
• Understanding of operational process implication caused by product registration status changes.
If you are interested please email your profile ASAP
Registered EA personnel(Rgn no: R1436009)
Talent Acquisition Group (TAG)
Phone: +65 6337 8471 #115/HP 83747245