Regulatory Affairs Executive (Medical Devices)

Our client who is a leader in the medical devices industry is looking for a capable Regulatory Affairs Executive to coordinate the registration and market access process, ensuring that product launch schedules are met, and that customer satisfaction is achieved.

Responsibilities:

The Regulatory Affairs Executive will:

  • Coordinate the process of product registration and market access approval for Singapore, Malaysia and Vietnam markets, including providing all required documents and certificates to achieve product registration in the shortest possible time
  • Provide advice to internal and external teams in interpreting RA documents and standards
  • Analyse and make recommendations regarding complaints received and whether they are reportable within the designated areas. Participate in post-market surveillance activities as necessary
  • Contact local authorities and organisations in designated countries to resolve regulatory issues and obtain updated information on current and developing regulations
  • Communicate any key regulatory changes to stakeholders in the broader organization
  • Provide training for internal stakeholders and assist with the development of the respective countries’ Regulatory Affairs infrastructure to facilitate greater speed to market
  • Support various teams and projects to define regulatory requirements for the designated sales areas, including product classification and type of regulatory submission required.

Requirements:

  • Degree in Chemistry/Pharmacy/Biology/Biomedical Engineering
  • At least 2 years of relevant experience in product, business processes/procedures, regulatory frameworks, and requirements for Medical Devices
  • Proficient in English and one local language, both written and verbal
  • Strong organization and time management skills.

Interested candidates are to submit their resume in MS Word format with current and expected salary, notice period and reason for leaving. We regret that only shortlisted candidates will be notified.

Reg: R1984660 Agency Lic: 06C4985

 

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