Regulatory Affairs Manager (Permanent, $6000, 5days, Tampines)

Posted 2 months ago

Regulatory Affairs Manager (Permanent, $6000, 5days, Tampines)

Company Background: A large multi-national company who is in distribution of medical / dental consumables and disposables to clinics and hospitals. This role is responsible for regulatory submissions and compliance for new and existing products in ASEAN region

Job Responsibilities:-

  • Maintain registration database, compile dossiers for production registration, change notifications and renewals according to requirements
  • Assist in registration plans for new products, variations, modifications, registration renewals
  • Involve in registration complexity analysis, registration plans for new products, variations, modifications and registration renewals
  • Assist in collecting and analysing regulatory intelligence, and incorporate regulatory trends into decision-making processes
  • Approval of product labelling with local regulations
  • Keep track of regulatory requirements changes in the region and maintain framework and product labelling comply with local regulations
  • Provide post market regulatory support and guidance as required

Job Requirements:-

  • Degree in Chemistry, Life Sciences, Engineering or related discipline with minimum 5 years of relevant working experience in healthcare devices manufacturing industry
  • Very good knowledge of regulations and requirements for medical devices, GDPMDS (Good Distribution Practice for Medical Devices), EU Medical Device Directive / Regulation, US FDA guidance, ISO standards (13485, 9001)
  • Work hour: 9am to 5:30 pm
  • Work Schedule: 5 days’ work week (Monday to Friday)
  • work location: Tampines
  • Salary: up to S$ 6000 per month

We thank you for your interest in this position, applicants with relevant experience please send Microsoft word resume with expected salary to for faster processing. Alternatively, please visit for more jobs available, thank you.

Shortlisted candidates will be contacted for interview session via phone. Thank you very much.

Agency License No. 12C6200 / EA Personnel No.: R1548977

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