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!