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RA Specialist (1 year contract)

Keywords / Skills : Excel

1 - 1 years
Posted: 2018-11-09

Nationality
Singapore
Industry
Recruitment/Staffing/RPO
Function
Sales/ Business Development
Role
Business Development
Posted On
9th Nov 2018
Job Ref code
8780
Job Description
Rare opportunity to work with a global medical devices provider Work location is centralised in CBD Exposure to wide array of product portfolio A leading global medical devices provider is inviting highly motivated, independent and meticulous regulatory affairs specialist to join their vibrant team. Reporting to the senior RA specialist and RA manager, 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 to develop strategies or to update on statuses. You will also have opportunities to work on special projects from time-to-time. Responsibilities Involved in the development of regulatory and/or supply strategies for various product range and changes, according to company’s requirements by reviewing strategies with various relevant stakeholders and discuss on action plans. Liaise with various countries’ regulatory affairs personnel, registration agents, distributors, sales & marketing and other relevant stakeholders, to understand and evaluate the requirements for product registrations for the designated market. Work closely with various regulatory affairs personnel and distributors to obtain country requirements for new product registration and/or license amendments for the designated and/or impacted market(s). Share the details with various countries’ regulatory affairs personnel for regulatory change impact. Follow-up closely with all stakeholders for all change impact assessment and report status to supervisor and stakeholders regularly. Compile dossiers for preparation of submissions in a timely manner. Exercise due diligence in reviewing technical documents to fulfill different regulatory bodies’ requirements. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale per regional guidelines. Monitor and update registration statuses to all relevant stakeholders in regular basis. Identify and report any delay to the registration timeline and involve the relevant stakeholders for discussion on action plan. Requirements Diploma holder with minimum 1 year working experience in healthcare industry preferred Good communications skills in English (both oral and written) to facilitate accurate information flow between departments Experienced with Microsoft Word and Excel 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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