Regulatory Affairs Specialist

PASONA SINGAPORE PTE. LTD.; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A leading medical device company in Singapore is seeking a Regulatory Affairs Specialist. The successful candidate will manage regulatory strategies for high-risk medical devices, ensuring compliance with regulations. This role requires at least 3 years of experience in Regulatory Affairs, strong communication skills, and a detail-oriented approach. Familiarity with Japanese is a plus. Interested candidates should submit their resumes to the specified email for processing.

Qualifications

• Minimum 3 years of Regulatory Affairs experience for medical devices of at least Class C risk.
• Good communication skills to liaise with internal and external parties.
• Eyes for details to read and check the related documents such as practical law.
• Basic level in Japanese language to liaise with Japanese-speaking counterparts in Japan will be a plus but not a must.

Responsibilities

• Propose strategic regulatory application and carry it out.
• Assess regulatory requirements and develop regulatory strategies for new products.
• Compile technical files and documentation necessary for regulatory submissions.
• Maintain up-to-date documentation and archival regulatory submissions.
• Ensure staff’s compliance with SOPs.

Skills

Regulatory Affairs experience

Communication skills

Attention to detail

Basic Japanese language

Job description

Regulatory Affairs Specialist / Senior Specialist

Our client, a medical device manufacturing company, is looking for a Regulatory Affairs Specialist / Senior Specialist. The successful candidate should have experience with products in Class C or D medical devices that are of high risk.

Job Responsibilities

• Responding to company policy and company requirements, propose strategic regulatory application and carry it out.
• Assess regulatory requirements and develop regulatory strategies for the qualifications of new products in the company's territories.
• Compile technical files, test reports and documentation necessary for regulatory submissions.
• Maintain up-to-date documentation, archival regulatory submissions, and related documents according to the company’s documentation policies and procedures.
• Maintenance of GDPMDS and ensuring staff’s compliance with SOPs.
• Coordination with internal/external people for application/query response document procurement.
• Coordination with the other govt. authorities as and when required and instructed by upper-rank personnel.
• Collect and compile regulatory information/updates and report to upper-rank personnel and people involved.

Schedule Management

• Manage schedules for regulatory submissions and make adjustments with an understanding of the importance of company policy and company requirements.
• Regarding schedule change, report upper-rank personnel and people involved in a timely manner.

Post-marketing Activities

• Coordination with the relevant people (Sales/Marketing, GHQ-QA) and report to authorities if necessary.

Industrial Activity

• Participate industrial activities and negotiate with authorities.

Others

• Follow your supervisor’s instructions and other ad-hoc duties as assigned.

Job Requirements

• Minimum 3 years of Regulatory Affairs experience for medical devices of at least Class C risk.
• Good communication skills to liaise with internal and external parties.
• Eyes for details to read and check the related documents such as practical law.
• Basic level in Japanese language to liaise with Japanese-speaking counterparts in Japan will be a plus but not a must.

Application Instructions

Interested applicants, please send your resume to Tiffany (R1104633) [e-mail] with email subject header “Job Application for Regulatory Affairs Specialist (Class C or Class D Medical Devices) - TK” for immediate processing.

We regret that only shortlisted candidates will be notified. Other applications will be updated to our database for future job opportunities.

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Pasona Singapore Pte Ltd

EA License No:90C4069

R1104633

Koh Jia Wen