Regulatory Affairs Specialist

JAC Recruitment Pte Ltd; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading global medical device company in Singapore is looking for a Regulatory Affairs Specialist. The ideal candidate will have at least 2 years of regulatory affairs experience in the medical device sector, strong knowledge of APAC regulations, and the ability to effectively collaborate across functions. Key responsibilities include coordinating product registrations, advising teams on regulatory matters, and liaising with local authorities on compliance. Join a company dedicated to improving healthcare outcomes worldwide.

Qualifications

• Minimum of 2 years of experience in regulatory affairs, particularly in medical devices.
• Strong understanding of medical device regulations.
• Excellent skills in communication and problem-solving.

Responsibilities

• Coordinate product registration and market access approval in APAC countries.
• Provide guidance on regulatory standards to teams.
• Liaise with authorities for regulatory updates and solve issues.

Skills

Regulatory compliance

Problem-solving

Communication skills

Attention to detail

Job description

Job Title: Regulatory Affairs Specialist

Location: Singapore

About Us: Join a leading global medical device company dedicated to advancing healthcare and improving patient outcomes worldwide. With a strong commitment to quality, innovation, and patient safety, they are expanding their reach across the dynamic Asia-Pacific markets.

Key Responsibilities

• Coordinate product registration and market access approval in designated APAC countries.
• Provide expert advice on interpreting regulatory guidance and standards to internal and external teams.
• Liaise with local authorities for regulatory problem-solving and to obtain updated information on developing regulations. Lead comprehensive post-market surveillance activities, including complaint reporting, analysis, FSCA, and recall coordination.

Qualifications

• At least 2 years of experience in regulatory affairs within the medical device industry.
• Strong knowledge of medical device regulations and the APAC regulatory landscape (including post-market surveillance).
• Proactive, detail-oriented, with excellent communication and problem-solving skills.
• Ability to collaborate effectively across functions and manage multiple tasks.

Interested applicants, please click APPLY NOW.

Please note, only shortlisted candidates will be contacted.