Senior Regulatory Affairs Specialist - MedTech SaMD
Heng & Hurst – Sydney NSW
Hybrid
7d ago , from Illawarra Mercury Job Board
Sydney
Pharmaceutical / Medical
Drive global regulatory pathways. Lead FDA submissions & promotional claims. Strong brand with growing portfolio of products. Hybrid/flexible working.
Drive global regulatory pathways. Lead FDA submissions & promotional claims
Career visibility, hybrid working & flexibility
Strong brand with growing portfolio of products
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.
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.
In this role, you will be:
Developing regulatory strategies for new products, product changes and lifecycle activities
Preparing and managing FDA 510(k), EU MDR, TGA, Health Canada and other global submissions
Leading interactions with regulatory bodies,



including FDA Q-Sub meetings and Notified Body communications
Managing responses to regulatory queries and deficiency requests
Providing regulatory guidance on marketing claims, labelling and intended use statements
Reviewing design control, risk management and verification/validation documentation
Supporting compliance with ISO, MDSAP and applicable global regulations
Monitoring regulatory changes and translating them into business actions
Experience with Software as a Medical Device (SaMD) and cybersecurity requirements will be highly regarded.
What you'll bring to be successful in this role:
Degree-qualified in Science, Engineering or a related discipline
5+ years' Regulatory Affairs experience within the medical device industry
Proven experience managing FDA 510(k) submissions
Strong understanding of global medical device regulations, including FDA and EU MDR
Knowledge of advertising and promotional claims requirements
Excellent stakeholder management skills
Solid analytical thinking and a practical, risk-based approach to decision-making.
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 (Sydney)
🏢 Heng & Hurst
📍 Sydney