Senior Regulatory Affairs Manager – Medical Devices

Premier Inn Hotels LLC (UAE); Petaling Jaya; On-site; MYR 78,000 - 89,000; Full time

Job summary

Premier Inn Hotels LLC (UAE) in Malaysia invites a Regulatory Affairs expert to lead compliance for medical devices in Malaysia, Singapore, and Indonesia. You will manage registrations, licensing, and post-market obligations.

You will collaborate with authorities, suppliers, and internal teams to implement ISO 13485, GDPMD, and other standards, while driving process improvements and RA audits. Applicants should have a science degree, 7+ years’ experience, and strong communication and leadership

Qualifications

• Bachelor's degree in Science or related field
• 7+ years regulatory experience in medical devices
• Experience with regulatory compliance in Malaysia, Singapore, and Indonesia
• Strong leadership and coaching skills

Responsibilities

• Ensure medical device regulatory compliance across markets
• Register devices and handle post-market reporting
• Oversee licenses and interactions with authorities
• Drive regulatory affairs digitization and process improvements
• Coordinate with authorities and stakeholders

Skills

Regulatory knowledge

Team leadership

Communication

Analytical skills

Process improvement

Regulatory compliance

Education

Bachelor's Degree in Science

Tools

Microsoft Office

Job description

Premier Inn Hotels LLC (UAE) in Malaysia invites a Regulatory Affairs expert to lead compliance for medical devices in Malaysia, Singapore, and Indonesia. You will manage registrations, licensing, and post-market obligations.

You will collaborate with authorities, suppliers, and internal teams to implement ISO 13485, GDPMD, and other standards, while driving process improvements and RA audits. Applicants should have a science degree, 7+ years’ experience, and strong communication and leadership