Job Description

Description

Job Responsibility:

• Prepare and maintain a listing of all registered products in all markets and maintain its renewal in a timely manner. Working closely with market authorized representative by providing all the necessary documents for dossier submission. Keeping track of legislation changes and advise on the legal and scientific restraint and requirements, collect, collate and evaluate scientific data.
• Ensure local and international market regulatory requirements are in compliance (HSA, TGA, FDA, EU, others as applicable).
• Participate in regulatory inspection by the regulatory authorities and certification bodies.
• Participate and assist to provide material/information required by Regulatory Authority for import, reimbursement and product registration.
• Any other tasks or projects that are being assigned by the immediate supervisor, as and when required.
• Prepare and maintain the registry of all products registered locally and internationally.
• Prepare and maintain the markets regulatory requirements for implementation in the company.
• Follow-up on any pre-market information and data required for dossier submission to the market authorized representative for new product registration.
• Assist in data collection from market authorized representatives for post market surveillance.
• Update the relevant standards, regulatory guidelines and essential requirements.
• Support in any product recall activities in the markets as required.
• Liaise with regulatory authority on factory inspection and work with QA on inspection preparation.
• Participate in the internal and external quality audits, and inspections.
• Work with sales and marketing, and QA team on label requirements.

Job Requirements:

• Min. Diploma in any field
• Min. 1-2 years relevant experienced in QA / RA
• Has prior knowledge in local and international market regulatory requirements

Candidates interested can email me at alexgoh@recruitexpress.com.sg

*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

Alex Goh Hock Leong (Alvin)

Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R1763413

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device
Others
Production / Manufacturing

Specialization

Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs
Others

Location

West

Employment Type

Contract / Temp

Salary

S$2,601 - S$4,000 / mth

Candidates interested can email me at alexgoh@recruitexpress.com.sg

*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

Alex Goh Hock Leong (Alvin)

Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R1763413