Regulatory Affairs Specialist – MP Biomedicals Asia Pacific Pte Ltd in Tuas, Singapore

Company MP Biomedicals Asia Pacific Pte Ltd is offering job opportunities for the position of Regulatory Affairs Specialist in the Tuas area. The job type available is Full-time.

We are looking for candidates who possess skills with beginners/seniors experience. We value honesty, discipline, and responsibility in our employees.

MP Biomedicals Asia Pacific Pte Ltd operates in the (according to the company) industry. If you are interested in applying to this company, please proceed with your application.

Job Information

Job Description

Basic Functions:

• Support in new product registrations, variations, and renewals for MP AP’s product

Duties:

• Prepare documents for registration to countries
• Co-work with sales/marketing for providing documentation supports to countries
• Maintain registration dossier properly
• Support in updating CE technical documents annually
• Assist in Notified Board audit and review
• Ensure the registration database is updated and inform the relevant departments for any changes
• Monitor global regulations/standards actively
• Verify the labelling accurately per regulatory requirements
• Assist in internal/external audit

Requirements:

Ability to:

• Understand how to review technical documents and provide feedbacks to R&D if there is any regulation update
• Compile the registration documents correctly and efficiently

Knowledge of:

• Regulations/standards for medical devices/In vitro diagnostics
• Technical terminology used in the laboratory

Education: Basic Science Degree

Experience: 1-2 years in RA/QA or in medical device/IVD industries

Job Types: Full-time, Permanent

Schedule:

• Monday to Friday

Work Location: In person

Benefit

• Comfortable environment
• Taught when starting work
• Salary bonus for overtime

Application Requirements

• Relevant formal education
• Work experience in the related industry is a plus
• Ability to adapt and learn quickly

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