Regulatory Affairs Executive

Location Singapore
Job reference BBBH94668_1604654798
Salary S$5000 - S$8000 per month + Bonus
Consultant name Song Zhao Hui
Consultant email zhaohui.song@experis.com.sg
Consultant contact no. 62328817
EA License No. 02C3423
Consultant Registration No. R1761205


Job Summary
AI Clinical Research/Medical Device company is looking for RA Specialist to manage and sustain the effectiveness of Regulatory processes complying with up-to-date regulations
Responsibilities

  • Maintaining a deep understanding of new and existing regulations that may impact their organization's products and processes (i.e. 21 CFR Part 820, MDR, JQMS)
  • Using that understanding to standardize all business operations and establish clear, documented SOPs and Wis
  • Explaining and training regulations, SOPs and WIs to all employees and stakeholders as necessary
  • Change Agent to new and revised regulations
  • Reviewing and approving marketing, legal, and technical documentation
  • Preparing and maintaining of technical dossier for product registration
  • Ensure management is up to date of the latest and changes regulatory requirements
  • Maintain up to date product registration status
  • Establish and maintain Advisory Notice and MDR process ensuring response time comply with regulatory requirements in established markets
  • Liaison to Local Authorised Representatives and International Agencies on product registration and resolving of regulatory matters
  • Other jobs assigned by supervisor


Experience / Training

  • 5years experience in Regulatory
  • Hands-on experience on product registration
  • Regulatory experiences in Asia (Japan, China and Middle East added advantage)
  • Experience with SaMD regulatory requirement


Education

  • Bachelor's Degree or equivalent experience in Science, Engineering, Regulatory or Medical Device, Pharmaceutical industry

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

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