RA 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 seeking a Regulatory Affairs Specialist to coordinate product registration and market access in the APAC region. The ideal candidate has at least 2 years of experience in regulatory affairs within the medical device industry, with strong knowledge of relevant regulations. This role emphasizes proactive problem-solving, effective collaboration, and detailed oversight of post-market activities. Interested applicants are encouraged to apply.

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).
• Ability to collaborate effectively across functions and manage multiple tasks.

Responsibilities

• Coordinate product registration and market access approval in designated APAC countries.
• Provide expert advice on interpreting regulatory guidance and standards.
• Liaise with local authorities for regulatory problem-solving.
• Lead post-market surveillance activities, including complaint reporting and recall coordination.

Skills

Proactive attitude

Excellent communication skills

Problem-solving skills

Detail-oriented

Job description

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.