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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