Regulatory Affairs Specialist, Medical Devices (Class C/D)

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

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.