APAC Regulatory Affairs Specialist: Global Impact

Penumbra; Singapore; Hybrid; SGD 70,000 - 90,000; Full time

Job summary

A global healthcare company is seeking a Regulatory Affairs Specialist in Singapore to manage submissions for regulatory approvals and ensure compliance with applicable regulations. The ideal candidate has at least 3 years of experience in the medical device industry and a bachelor's degree in a scientific discipline. This role requires strong communication skills and attention to detail, with a focus on working in a collaborative environment.

Qualifications

• 3+ years of relevant regulatory experience in the medical device industry or equivalent.
• Working knowledge of ISO 13485 and medical device regulations.
• Success in creating and submitting regulatory submissions.

Responsibilities

• Prepare submissions for regulatory approvals.
• Communicate with regulatory authorities and distributors.
• Maintain compliance with U.S. and international regulations.

Skills

Regulatory submissions

Communication skills

Attention to detail

Organizational skills

Quality systems knowledge

Proficiency in MS Office

Education

Bachelor's degree in a scientific discipline or related field

Job description

A global healthcare company is seeking a Regulatory Affairs Specialist in Singapore to manage submissions for regulatory approvals and ensure compliance with applicable regulations. The ideal candidate has at least 3 years of experience in the medical device industry and a bachelor's degree in a scientific discipline. This role requires strong communication skills and attention to detail, with a focus on working in a collaborative environment.