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 hr@machspeed.com.sg for faster processing. Alternatively, please visit http://www.facebook.com/MachspeedHR 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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