Senior Regulatory Affairs Specialist (Medtech)

TL;DR

Senior Regulatory Affairs Specialist (Medtech): Managing regulatory submissions and compliance for medical devices in domestic and international markets with an accent on FDA and CE certification processes. Focus on coordinating premarket notifications, maintaining technical files, and ensuring adherence to global regulatory standards for life-saving acute care technology.

Location: Must be based in Selangor, Malaysia

Company

hirify.global Corporation is a global leader in medical devices and software solutions dedicated to improving patient outcomes for cardiopulmonary and respiratory conditions.

What you will do

• Prepare and maintain regulatory submissions including FDA 510(k), PMA, and CE technical files.
• Represent regulatory affairs in cross-functional project teams, risk management, and design reviews.
• Communicate directly with the US FDA, EU Notified Bodies, and other international regulatory authorities.
• Review product labeling, promotional literature, and marketing materials for regulatory compliance.
• Support CAPA processes and ensure timely closure of quality-related actions.
• Monitor new regulations and standards to ensure ongoing product compliance.

Requirements

• Bachelor's degree required.
• 6+ years of regulatory experience in the Medical Device Industry required.
• Proven experience with medical device regulatory submissions (510(k) or PMA).
• Strong knowledge of U.S. and European/International regulations and standards.
• Demonstrated ability to work under pressure and meet strict regulatory reporting deadlines.
• Excellent communication and interpersonal skills for cross-functional collaboration.

Nice to have

• Degree in Regulatory Affairs or Regulatory Affairs Certification (RAC).
• Familiarity with medical terminology.

Culture & Benefits

• Opportunity to work on life-saving medical technology with a global impact.
• Fast-growing company environment that values innovation and entrepreneurial spirit.
• Commitment to professional development and career growth.
• Collaborative team culture focused on patient outcomes.