Regulatory Affairs Specialist

Job Summary

We are seeking experienced, detail-oriented, and proactive Regulatory Affairs Specialists to support the registration and regulatory compliance of Class C medical device across international markets. Each specialist will be responsible for one or more assigned regions based on their expertise and will play a key role in securing product approvals, maintaining regulatory compliance, and supporting global market expansion.

Candidates with experience in both Regulatory Affairs (RA) and Quality Assurance (QA), as well as established relationships with regulatory authorities, will be highly preferred.

Key Responsibilities

• Lead end-to-end regulatory registration activities for Class C medical devices, including regulatory strategy, technical documentation, product testing, clinical evaluations, quality system documentation, and submissions.
• Manage regulatory registrations, renewals, amendments, and change notifications for assigned markets.
• Prepare and submit regulatory filings in accordance with the requirements of the assigned region(s).
• Act as the primary liaison with regulatory authorities, notified bodies, and local registration partners to facilitate timely approvals and address regulatory inquiries.
• Monitor submission timelines and proactively manage regulatory milestones to support product launches and lifecycle management.
• Maintain accurate and up-to-date regulatory documentation, technical files, product registrations, and regulatory records.
• Collaborate closely with internal teams to ensure regulatory and quality compliance throughout the product lifecycle.
• Provide regulatory guidance on product development, labeling, design changes, and market entry strategies.
• Monitor changes to applicable regulations within assigned markets and assess their impact on existing and future products.
• Perform other duties as assigned.

Candidate Requirements

• Bachelor's Degree in Life Sciences, Biomedical Engineering, Engineering, or a related discipline.
• Minimum 1-3 years of Regulatory Affairs experience within the medical device industry.
• Hands-on experience with Class C medical devices is highly preferred.
• Proven experience managing end-to-end product registrations, renewals, change notifications, and regulatory lifecycle activities.
• Experience in one or more of the following regulatory markets: Europe, United States, Canada or Southeast Asia (e.g. Singapore, Malaysia, Thailand, Indonesia, Philippines, Vietnam)
• Experience in both Regulatory Affairs (RA) and Quality Assurance (QA) is preferred.
• Established working relationships or experience liaising with regulatory authorities, notified bodies, or local regulatory agencies is an advantage.
• Strong understanding of medical device regulations, quality management systems, and applicable international standards.
• Excellent organizational, analytical, and project management skills, with the ability to manage multiple regulatory submissions simultaneously.
• Strong written and verbal communication skills in English. Additional language proficiency is an advantage.
• Self-motivated, detail-oriented, and able to work effectively in a cross-functional, international environment.