RA Executive

CLEARLAB SG PTE. LTD.; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A leading medical device company in Singapore is seeking an experienced Regulatory Affairs Specialist to manage technical documentation and ensure compliance with. The successful candidate will prepare application documents for various regions such as EU, US, and Singapore. The role requires at least 3-4 years of relevant experience, proficiency in Microsoft Office, and strong knowledge of regulatory standards including EU MDR and ISO 13485. This position offers a dynamic work environment and opportunities for professional growth.

Qualifications

• At least 3-4 years of experience in regulatory affairs within the medical device or GMP-related industry.
• Knowledge of EU MDR 2017/245 and ISO 13485 requirements.
• Fluent in English, both verbal and written.

Responsibilities

• Prepare and compile all necessary application and technical documentation for marketed countries.
• Conduct and compile Post-Market Surveillance activities.
• Update and maintain Product Registration and related licenses.
• Support QMS activities to ensure compliance with regulatory requirements.
• Assist in internal and external audits.

Skills

Technical Documentation

Microsoft Office

Regulatory Affairs

FDA

ISO

GMP

Compliance

Packaging

Audits

Food Safety

Food Science

HACCP

Surveillance

Raw Materials

Education

Diploma in any science field

Job description

Prepare and compile all necessary application and technical documentation for all marketed countries, including EU CE, US FDA, and Singapore HSA for Clearlab Group.

Conduct and compile Post-Market Surveillance activities, including Adverse Event Reporting, Product Recall, and Periodic Safety Update Reports (PSUR) for Clearlab Group.

Update, monitor, and maintain Product Registration, Trademark License Listing, and other related licenses for marketed countries.

Update and maintain Technical Files, CSDT, and any relevant Product Registration Technical Files.

Update and maintain Artworks and Packaging Labels, including Device Labels and IFU for all marketed regions.

Support QMS activities to ensure compliance with regulatory requirements.

Assist in internal and external audits and perform other ad‑hoc duties as needed.

Support the Document Control Centre as required.

Responsibilities

• Prepare and compile all necessary application and technical documentation for all marketed countries, including EU CE, US FDA, and Singapore HSA for Clearlab Group.
• Conduct and compile Post-Market Surveillance activities, including Adverse Event Reporting, Product Recall, and Periodic Safety Update Reports (PSUR) for Clearlab Group.
• Update, monitor, and maintain Product Registration, Trademark License Listing, and other related licenses for marketed countries.
• Update and maintain Technical Files, CSDT, and any relevant Product Registration Technical Files.
• Update and maintain Artworks and Packaging Labels, including Device Labels and IFU for all marketed regions.
• Support QMS activities to ensure compliance with regulatory requirements.
• Assist in internal and external audits and perform other ad‑hoc duties as needed.
• Support the Document Control Centre as required.

Requirements

• Diploma in any science field.
• At least 3‑4 years of experience in regulatory affairs within the medical device or GMP‑related industry.
• Knowledge of EU MDR 2017/245 and ISO 13485 requirements.
• Proficient in Microsoft Office (MS Excel, MS Word).
• Fluent in English, both verbal and written.

Skills

• Technical Documentation
• Microsoft Office
• FDA
• Food Safety
• Labels
• Regulatory Affairs
• ISO
• GMP
• Raw Materials
• Surveillance
• Compliance
• Packaging
• Audits
• Food Science
• HACCP