Job Description
Senior Regulatory Affairs Specialist - MedTech SaMD
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Heng & Hurst – Sydney NSW
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Hybrid
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7d ago , from Illawarra Mercury Job Board
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Sydney
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Pharmaceutical / Medical
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Drive global regulatory pathways. Lead FDA submissions & promotional claims. Strong brand with growing portfolio of products. Hybrid/flexible working.
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Drive global regulatory pathways. Lead FDA submissions & promotional claims
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Career visibility, hybrid working & flexibility
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Solid brand with growing portfolio of products
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We're partnering with an innovative medical device organisation that develops technology-driven healthcare solutions used across global markets. As the business continues to expand internationally, they are seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy, submissions and compliance activities across their product portfolio.
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This is a high-impact role where you'll take ownership of FDA, EU MDR and international regulatory pathways, working closely with Quality, R&D; and Commercial teams to bring new products to market and maintain global
compliance.Reporting
to the Head of Scientific Affairs, you'll play a key role in supporting product development, market access and lifecycle management activities.
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In this role, you will be:
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Developing regulatory strategies for new products, product changes and lifecycle activities
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Preparing and managing FDA 510(k), EU MDR, TGA, Health Canada and other global submissions
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Leading interactions with regulatory bodies, including FDA Q-Sub meetings and Notified Body communications
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Managing responses to regulatory queries and deficiency requests
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Providing regulatory guidance on marketing claims, labelling and intended use statements
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Reviewing design control, risk management and
verification/validation
documentation
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Supporting compliance with ISO, MDSAP and applicable global regulations
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Monitoring regulatory changes and translating them into business actions
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Experience with Software as a Medical Device (SaMD) and cybersecurity requirements will be highly regarded.
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What you'll bring to be successful in this role:
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Degree-qualified in Science, Engineering or a related discipline
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5+ years' Regulatory Affairs experience within the medical device industry
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Proven experience managing FDA 510(k) submissions
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Strong understanding of global medical device regulations, including FDA and EU MDR
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Knowledge of advertising and promotional claims requirements
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Excellent stakeholder management skills
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Strong analytical thinking and a practical, risk-based approach to decision-making.
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This opportunity will suit a regulatory professional looking to move beyond compliance and play a strategic role in global product development and market access. You'll join a collaborative team environment and have the chance to influence cutting-edge technologies that improve patient outcomes worldwide.
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📌 Senior Regulatory Affairs Specialist - Medtech Samd (New South Wales)
🏢 Heng & Hurst
📍 New South Wales