Senior Regulatory Affairs Specialist - MedTech SaMD
- Drive global regulatory pathways for medical devices.
- Lead FDA submissions and promotional claims.
- Collaborate with cross-functional teams to ensure compliance and market access.
- 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
- Strong 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.
Apply here today, or contact Sam Pickering on 0497 880 146 for a confidential discussion ASAP!
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