Senior Regulatory Affairs Specialist, APAC (Medical Devices)

Location: Selangor, Malaysia

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions, including AEDs, trauma kits, ventilators, and temperature management solutions.

What you will do

• Prepare, coordinate, and maintain regulatory submissions for new and modified medical devices in domestic and international markets.
• Represent regulatory affairs on product teams, risk management activities, design reviews, and cross-functional projects.
• Develop regulatory strategies and plans, provide guidance on applicable standards, and communicate with FDA, EU Notified Bodies, EU Competent Authorities, and other regulatory agencies.
• Coordinate FDA PMA and 510(k) submissions, CE files, Essential Requirement checklists, certification updates, and responses to agency letters.
• Review product labeling and promotional materials, and support CAPA activities and closure.
• Monitor regulatory changes, participate in audits and inspections, and write SOPs and train personnel as needed.

Requirements

• Bachelor's degree required.
• 6+ years of regulatory affairs experience in the medical device industry.
• Experience preparing medical device regulatory submissions, including 510(k) or PMA submissions.
• Previous experience working with regulatory authorities on premarket and compliance activities.
• Knowledge of U.S., European, and international regulations and standards, with experience interacting with FDA or other regulatory agencies.
• Strong project management, analytical, communication, writing, prioritization, and leadership skills; ability to work independently and meet regulatory deadlines.

Nice to have

• Degree in regulatory affairs or a Regulatory Affairs Certification.
• Familiarity with medical terminology.

Culture & Benefits

• Work in a fast-growing organization operating in more than 140 countries.
• Collaborate with quality assurance, manufacturing, program management, product development, and marketing teams.
• Approximately 10% travel is required.
• Contribute to technologies designed to improve outcomes for patients with critical cardiopulmonary conditions.