Regulatory Affairs & Quality Assurance Leader

Merit-Medical-Systems-Inc.; Jakarta Pusat; On-site; IDR 150,000,000 - 250,000,000; Full time

Job summary

Merit Medical is seeking a Regulatory Affairs professional in Jakarta to lead registrations, renewals, and license maintenance with the Indonesian Ministry of Health. You will write and maintain regulatory submission dossiers and coordinate approvals with local authorities.

The role requires 4–6 years in medical device regulatory affairs, strong documentation skills, and the ability to lead cross-functional teams in a global environment.

Qualifications

• Regulatory affairs experience in medical devices (4–6 years preferred).
• Experience in Indonesian Ministry of Health submissions and approvals.
• Ability to write regulatory dossiers and respond to questions from authorities.
• Strong documentation and regulatory tracking skills.

Responsibilities

• Register, renew, and license medical devices with Indonesian authorities.
• Write and maintain regulatory submission dossiers.
• Submit approvals and liaise with local regulatory agencies.
• Maintain product registration records and databases for partner countries.
• Manage post-market surveillance, complaints handling, recalls, and adverse event reporting.

Skills

Regulatory affairs

Regulatory submissions

Quality systems

Regulatory writing

Education

Bachelor's degree

Tools

MS Office

Job description

Merit Medical is seeking a Regulatory Affairs professional in Jakarta to lead registrations, renewals, and license maintenance with the Indonesian Ministry of Health. You will write and maintain regulatory submission dossiers and coordinate approvals with local authorities.

The role requires 4–6 years in medical device regulatory affairs, strong documentation skills, and the ability to lead cross-functional teams in a global environment.