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Senior Regulatory Affairs Executive - Medical Devices

Keywords / Skills : Senior Regulatory Affairs Executive - Medical Devices

3 - 3 years
Posted: 2018-12-01

Software Engineer/ Programmer
Posted On
1st Dec 2018
Job Ref code
Job Description
Amazing opportunity to join a global medical solutions provider Exposure to wide array of products portfolio and ASEAN countries Good company culture with great benefits A global renowned medical devices provider is inviting highly motivated, independent and meticulous senior regulatory affairs specialist to join their vibrant 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. Responsibilities Compile dossiers for preparation of submissions in a timely manner. Exercise 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. Liaise 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 Requirements Bachelor’s degree or equivalent in pharmacy or related scientific discipline Minimum 3 years of regulatory experience in medical device / 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).

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