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 RA

TELE me at @jacechooo or WA me at NOW!
Interested candidates please submit your resume to jacechoo@recruitexpress.com.sg

Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device

Specialization

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

Location

West

Employment Type

Permanent

Salary

Negotiable

If you meet the requirements of this role, please email a detailed resume in Word document to Jace Choo Oi Kei.
CEI Registration No.: R1875164
Email: jacechoo@recruitexpress.com.sg
Tel: 67363280
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

Recruit Express