Senior Regulatory Affairs Specialist

📋 Description

• Support regulatory strategies, submission activities, and compliance initiatives for advanced
• Serve as regulatory partner across product development, quality, and commercial teams.
• Prepare and manage regulatory submissions for relevant authorities.
• Coordinate communications with regulatory agencies during application reviews.
• Maintain product registrations, licenses, certifications, listings, and other regulatory
• Provide regulatory guidance to Product Development throughout the lifecycle.

🎯 Requirements

• Bachelor’s degree or equivalent in science/engineering/related field.
• Experience in regulatory affairs within medical device or therapeutic goods.
• Strong understanding of medical device regulations, quality systems, and ISO standards.
• Experience managing regulatory filings and cross-functional collaboration.
• Strong written and verbal communication, organizational, and analytical skills.
• Preferred experience with US, European, and/or Australian medical device regulations.

🎁 Benefits

• Opportunity to contribute to innovative medical technologies improving patient care.
• Collaborative environment focused on innovation and impact.
• Competitive compensation based on experience.
• Opportunities to work with multidisciplinary teams across development and commercialization.
• Professional growth through mentorship and exposure to global regulatory processes.
• Inclusive workplace culture valuing diverse perspectives.