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Assistant Regulatory Affairs Manager

Work Location: Joo Seng Rd
5 Days Work - Week
Industry: Manufacturing/Biotechnology

Responsibilities:

  • To maintain and renew the product / establishment licenses to compliance to applicable regulatory authorities’ requirements
  • To manage and ensure compliance on product registration and renewal activities of all countries where  products are marketed.
  • To provide regulatory advice on company’s business strategy and manage projects in the provisions of these regulatory affairs services.
  • To perform the yearly Post Market Assessment for products as required by regulations and standards.
  • To handle the specific product registration activities in EEA, Malaysia, Indonesia, Korea and new emerging markets as and when required.
  • To 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:

  • Bachelors Degree in any science or technical field
  • ISO 13485 certified | MDSAP certified
  • Minimum 5 years in quality or regulatory related experience
  • Experience in a medical device or GMP regulated industry
  • Understanding of related Regulatory and cGMP requirements
  • Understanding of Product Registration, Trademark and CE Mark
  • Able to use Microsoft Office - i.e. MS Excel, MS Words & MS Powerpoint
  • Results-oriented, meticulous and a self-motivated team player
  • Effective decision making capabilities


*Only shortlisted candidates will be notified.

How to apply:
Please forward your resume in MS WORD FORMAT to sjo@juhlerprofessionals.com.sg

EA Personnel: Shiela Joseph
EA Reg ID: R1986902
EA License No: 01C3135

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