Regulatory Affairs Specialist
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Job Description
Regulatory Affairs Specialist providing regulatory expertise throughout the product lifecycle at Harrison.ai. Helping solve compliance challenges for Software-as-Medical-Device products.
Responsibilities:
- Creation and maintenance of Technical Files
- Compilation of regulatory dispatches in accordance with global requirements and management of regulatory submissions to achieve successful regulatory approval
- Collaborate with internal stakeholders to prepare and submit responses to questions from regulatory authorities and notified bodies
- Liaise with authorised representatives and regulatory authorities
- Solve complex registration and compliance challenges with a focus on delivering business results through collaboration, accountability and innovation
- Assess the regulatory impact of new products/product changes to facilitate the timely commercialisation of new or modified products in global markets
- Review product labelling and promotional material for regulatory compliance
- Provide ongoing regulatory advice to project teams to ensure regulatory requirements are met
- Vigilance reporting/recall notification with regulators and/or country representatives
- Comply with all company policies, procedures and guidelines including those relating to information security
- Keep up to date on new and evolving regulatory intelligence
Requirements:
- Degree in software, engineering, science or related discipline
- Minimum 2 years’ experience in a Medical Device Regulatory Affairs role.
- Sound understanding of global medical device registration processes, especially TGA and EU MDR
- Excellent attention to detail and ability to multi-task and balance competing priorities.
- Ability to build relationships between Regulatory Affairs and other areas of the business to work adhesively at all levels.
- Ability to work autonomously.
Benefits:
- Innovate for Global Good. Join us to pioneer world-first AI technology that transforms patient outcomes and helps build a healthier, fairer world.
- Collaboration Across Continents. Work with brilliant minds from every corner of the globe in a culture built on trust, autonomy, and genuine teamwork.
- Well-Funded & Global. Backed by world-class investors including Aware Super, Blackbird Ventures, Skip Capital, and Horizons Ventures, we’ve raised over US$240M to accelerate our global impact.
- Scale Your Potential. Tap into yearly L&D budgets, mentoring, hackathons, and secondments—all supported by a transparent growth framework to grow your career.
- Flex for Life. Work when and where you do your best—with WFH options, flexible hours, and the autonomy to make an impact your way.
- Support for Every Family Journey. From fertility to parenthood, loss, and even grandparenthood—we provide inclusive, thoughtful policies to support families in every stage.
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