Assistant Regulatory Affairs Manager

Location Singapore
Discipline Healthcare & Medical
Job Reference BBBH101260_1625629400
Salary AWS
Consultant Name Song Zhao Hui
Consultant Email zhaohui.song@manpower.com.sg
Consultant Contact No. 62328817
EA License No. 02C3423
Consultant Registration No. R1761205


Responsibilities:

  • Act as Person Responsible and RA Manager for company to register, maintain and renew the product / establishment licenses to compliance to applicable regulatory authorities' requirements
  • Manage and ensure compliance on product registration and renewal activities of all countries where company products are marketed.
  • Provide regulatory advice on company's business strategy and manage projects in the provisions of these regulatory affairs services.
  • Perform the yearly Post Market Assessment for both contact lens and lens care products as required by regulations and standards.
  • Perform 510K pre-market notifications for products registered in relevant countries.
  • Handle the specific product registration activities in EEA, Malaysia, Indonesia, Korea and new emerging markets as and when required.
  • Ensure regulatory compliance by completing the appropriate filings and documentation pertaining to the company's product registration/approvals, as required by internal procedures relating to Singapore and International regulatory requirements.


Requirements:

  • Minimum Bachelor's Degree in any science or technical field
  • ISO 13485 certified. MDSAP certified
  • Minimum 5 years in quality or regulatory related experience
  • Minimum 3 years working experience in a medical device or GMP regulated industry
  • Minimum 3 years in supervisory or management role
  • Understanding of MDSAP, EU MDR 2017/745, MDD 93/42/EEC, ISO 13485 requirements and ISO 9001 requirements
  • Understanding of related Regulatory and cGMP requirements
  • Understanding of Product Registration, Trademark and CE Mark
  • Possess strong management skills and leadership, positive attitude and good interpersonal skills
  • Able to use Microsoft Office - i.e. MS Excel, MS Words & MS Powerpoint

Song Zhao Hui EA License No. 02C3423 Personnel Registration No. R1761205

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