Senior Regulatory Affairs Specialist

Accountabilities:
As a Senior Regulatory Affairs Specialist, you will support regulatory strategies, submission activities, and compliance initiatives for a portfolio of advanced medical device products. You will serve as a key regulatory partner across product development, quality, and commercial teams. Prepare and manage regulatory submissions for relevant authorities, ensuring accuracy, completeness, and alignment with applicable requirements. Coordinate communications with regulatory agencies during application reviews and support timely responses to regulatory questions. Maintain product registrations, licenses, certifications, listings, and other regulatory documentation. Provide regulatory guidance and strategic input to Product Development teams throughout the design and development lifecycle. Assess product, design, quality, and manufacturing changes to determine regulatory impact and submission requirements. Review technical documentation to ensure compliance and readiness for regulatory submissions. Monitor updates to regulations, standards, and industry guidance to support ongoing compliance. Support the development and review of product labeling, promotional materials, and other customer-facing content for regulatory compliance. Collaborate with cross-functional teams including engineering, quality, clinical, and commercial stakeholders to achieve regulatory objectives. Mentor and support junior regulatory affairs specialists and interns by sharing knowledge and best practices. Requirements: The ideal candidate brings strong regulatory affairs expertise within the medical device or healthcare industry, with the ability to manage complex submissions, collaborate across teams, and navigate evolving regulatory environments. Bachelor’s degree or equivalent qualification in a science, engineering, biomedical, software, mechanical, or related technical discipline. Experience working in regulatory affairs within the medical device or therapeutic goods industry. Strong understanding of medical device regulations, quality systems, and relevant ISO standards related to product development and approval. Demonstrated experience managing, compiling, submitting, and maintaining regulatory filings. Experience supporting cross-functional teams in a commercial product environment. Strong written and verbal communication skills with the ability to communicate technical information clearly. Excellent organizational skills with the ability to manage multiple priorities and work independently. Strong analytical capabilities, problem-solving skills, and attention to detail. Self-motivated, collaborative, and committed to maintaining high standards of integrity and quality. Passion for contributing to the growth and success of innovative healthcare solutions. Preferred experience with U.S., European, and/or Australian medical device regulations. Preferred experience with active implantable medical devices, Class III medical devices, or reimbursement requirements. Benefits: Opportunity to contribute to innovative medical technologies improving patient care. Collaborative environment focused on innovation, integrity, and meaningful impact. Competitive compensation package based on experience and qualifications. Opportunity to work with multidisciplinary teams across product development and commercialization. Professional growth opportunities through mentorship, collaboration, and exposure to global regulatory processes. Inclusive workplace culture that values diverse perspectives, expertise, and contributions.

How Jobgether works:
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