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.