APAC Regulatory Affairs Specialist — Global Impact

Penumbra, Inc.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A global healthcare company is seeking a Regulatory Affairs Specialist in Singapore. This role involves preparing regulatory submissions and ensuring compliance with medical device regulations. The ideal candidate has a Bachelor's degree and over 3 years of experience in regulatory affairs within the medical device industry. Proficiency in MS Office and strong communication skills in English are essential.

Qualifications

• 3+ years of relevant regulatory experience in medical device or related industry.
• Working knowledge of ISO 13485 and GDPMD.
• Strong attention to detail and accuracy.

Responsibilities

• Prepare submissions for regulatory approvals.
• Communicate with regulatory authorities and consultants.
• Assist with Customs/Importation procedures.

Skills

Regulatory submissions

Quality systems

Communication skills

Organizational skills

Education

Bachelor's degree in a scientific discipline

Tools

MS Word

Excel

PowerPoint

Job description

A global healthcare company is seeking a Regulatory Affairs Specialist in Singapore. This role involves preparing regulatory submissions and ensuring compliance with medical device regulations. The ideal candidate has a Bachelor's degree and over 3 years of experience in regulatory affairs within the medical device industry. Proficiency in MS Office and strong communication skills in English are essential.