S$3800 - S$4600 per month
4 months ago
A fast-growing medical devices provider is inviting highly motivated, independent and meticulous regulatory affairs specialist to join their team. You will be responsible to compile dossiers in preparation of submissions for new products, variations or renewals. You will be interacting frequently with internal and external stakeholders, providing specific regulatory guidance and ensure that regulatory plans are in-sync with business requirements.
You will be responsible for:
- Compiling of dossiers for preparation of submissions in a timely manner across ASEAN regions. Exercising due diligence in reviewing technical documents to fulfill different regulatory bodies' requirements.
- Reviewing and ensuring promotional marketing materials and labels are in line with company's requirements and various regulatory requirements.
- Liaising with both internal and external stakeholders to ensure regulatory compliance and provide regulatory advice whenever necessary
- Assisting the RA manager in the development and implementation of regulatory strategies for various projects to ensure operational excellence and support business requirements
- Monitoring and maintaining of reports and databases
You will have:
- A diploma or degree in scientific discipline or equivalent discipline
- Minimum 3 years of regulatory experience in medical device, pharmaceutical or healthcare industry is preferred
- Good communications skills in English (both oral and written) to facilitate accurate information flow between departments
Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).