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RA Specialist (1 year contract)

Keywords / Skills : Excel

1 - 6 years
Posted: 2018-11-09

Nationality
Singapore
Industry
Recruitment/Staffing/RPO
Function
IT
Role
Software Engineer/ Programmer
Education
Diploma
Non Degree Tertiary
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).
Key Skill(s)

About Company

EA Registration No. 12C5526

Founded in 1950, and established in Asia in 2004, VOLT is a NYSE listed Fortune 1000 provider of talent (recruitment), technology and consulting services with 4,200 full time employees, some 30,200 contractors and 192 offices across Europe, North and South America and Asia.

Volt's workforce solutions include executive search, contract and temporary staffing, managed services programs, vendor management systems and recruitment process outsourcing. Volt combines consultative focus, Six Sigma practices and efficient e-procurement technologies to deliver the talent and processes that help our customers succeed.
We connect companies with industry-leading specialists. Our proven search process cultivates a superior network of active and passive professionals, enabling us to provide best-fit experts in a broad range of business disciplines.

Our areas of expertise include Accountancy & Finance, Engineering, Human Resources, Information Technology & Telecommunications, Life Sciences, Procurement & Supply Chain, Property, and Sales & Marketing.
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