Position Description

Regulatory Affairs Manager (Medical Device)
Job Code 18497
Job Placement Location Singapore
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Job Responsibilties

  • Manage and ensure compliance on product registration and renewal activities of all countries where the company's 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 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.

Job Requirements

  • Bachelors Degree in any science or technical field
  • ISO 13485 certified. MDSAP certified
  • Minimum 5 years in quality or regulatory related experience 
  • Minimum 5 years working experience in a medical device or GMP regulated industry.
  • Proficient in ISO13485 & MDSAP.

Only shortlisted candidate will be notified.
To apply, please visit to www.gmprecruit.com and search for Job Reference: 18497
To find out more about this opportunity, please contact Jaremy Ong at Jaremy.Ong@gmprecruit.com.
GMP Recruitment Services (S) Pte Ltd | EA Licence: 09C3051 | EA Personnel: Jaremy Ong | Registration No: R1876766

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