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, serving customers in more than 140 countries.

What you will do

• Prepare, coordinate, and maintain regulatory submissions for new and modified medical devices in domestic and international markets.
• Manage FDA PMA and 510(k) premarket notifications and maintain CE files, certification records, and essential requirements checklists.
• Develop global regulatory strategies and plans with department management and provide guidance on applicable regulations and standards.
• Represent regulatory affairs in product teams, risk management activities, design reviews, and cross-functional work with quality assurance, manufacturing, product development, program management, and marketing.
• Communicate with the US FDA, EU Notified Bodies, EU Competent Authorities, and other international regulatory agencies, including preparing responses to agency letters.
• Review labeling and promotional materials, support CAPA closure and regulatory audits, and write SOPs and train personnel as needed.

Requirements

• Bachelor’s degree.
• At least 6 years of regulatory affairs experience in the medical device industry.
• Required experience with medical device regulatory submissions, including 510(k) or PMA submissions.
• Previous experience working with regulatory authorities on premarket and compliance activities, including interaction with the FDA or other agencies.
• Knowledge of US, European, and international regulations and standards, as well as manufacturing and change control.
• Strong analytical, communication, writing, leadership, teamwork, prioritization, and project management skills; ability to work independently under regulatory deadlines.

Nice to have

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

Culture & Benefits

• Work in a fast-growing medical technology company focused on improving patient outcomes.
• Collaborate with teams supporting products for EMS, hospitals, public safety, and military customers.
• Culture values innovation, self-motivation, an entrepreneurial spirit, and commitment to underserved patients.
• Approximately 10% travel is required.