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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- Strong 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 recent 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 opportunity to influence innovative technologies that improve patient outcomes worldwide.

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📌 Senior Regulatory Affairs Specialist - MedTech SaMD (New South Wales)
🏢 Heng & Hurst
📍 New South Wales