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Assistant RA Manager

Keywords / Skills : Assistant RA Manager

6 - 6 years
Posted: 2019-02-12

Software Engineer/ Programmer
Posted On
12th Feb 2019
Job Ref code
Job Description
Fast growing IVD company with increasing clinical foothold in APAC regions Travelling opportunities across APAC and liaising with various regulatory authorities Amazing work culture and benefits A global IVD company is inviting meticulous, organized and highly motivated personal to join their regulatory affairs team as a RA manager. You will be reporting to the senior manager of regulatory affairs and assisting her regulatory submissions for new products, variations or renewals both locally and across APAC. 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 Submissions and following up of product registrations to various regulatory bodies in a timely manner. Exercise due diligence in reviewing technical documents to fulfill different regulatory bodies’ requirements. Liaise with both internal and external stakeholders to ensure regulatory compliance and provide regulatory advice whenever necessary Mentoring and training of internal team of regulatory specialists, APAC affiliates and business units/partners 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 Medical Science or related scientific discipline Minimum 6 years of regulatory experience in IVD or medical devices industry is preferred Good communications skills in English (both oral and written) to facilitate accurate information flow between departments Ability to travel (up to 20%) as the role covers across APAC regions 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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