Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist, Senior RA Specialist

As the Senior Regulatory Affairs Specialist, you will provide expertise in developing and implementing a clear global regulatory strategy and pathway to guide product development and commercialisation plans. You will apply your knowledge of regulatory, pharmacovigilance, and clinical requirements to lead product regulatory approvals and maintenance activities for markets including Europe, Australia, and the US. This role is also responsible for Clinical & Vigilance aspects of the Company's new and 'in-market' products.

Responsibilities:

• Lead product regulatory approval projects to ensure compliance with regulatory requirements for key markets, including Australia, Europe, the UK, and the US.
• Provide clear guidance on regulatory strategies for product realisation activities, collaborating with project teams using the Company's project management frameworks and adhering to required QMS.
• Manage the implementation, ongoing evaluation, prioritisation, reporting, and timely delivery of all operational aspects of allocated project's regulatory/clinical pathways.
• Foster a high-performing culture within areas of responsibility, bringing together cross-functional team members to deliver outcomes.
• Serve as the primary or secondary contact with regulatory authorities and strategic partners as appropriate.
• Maintain device and facility registrations with current technical documentation, such as FDA, TGA, and EUDAMED.
• Write and coordinate submissions for regulatory approval, both domestic and international, including FDA, Health Canada, TGA, and EU standards.
• Oversee all Post-Market Surveillance (PMS) and Vigilance activities to ensure ongoing device safety and maintenance of the appropriate risk-benefit balance, including vigilance reporting to regulatory authorities.
• Manage and monitor global clinical studies in conjunction with R&D, including identifying suitable study sites according to individual project requirements.
• Ensure that policies and procedures in place for conducting design validation/clinical studies according to applicable regulations.
• Review and approve project documents related to clinical studies and dossier preparation from a regulatory and clinical perspective.
• Liaise with commercial partners regarding regulatory and clinical strategies when required.
• Maintain effective professional relationships with external customers, investigators, vendors, clinical trial managers, and the internal project team, including those providing academic input.
• Obtain and distribute updated information regarding international and domestic regulatory laws, guidelines, and standards relevant to the Company and its products.

Skills:

• 5+ years in a medical device regulated environment.
• Strong understanding of ISO 9001, 13485, IVDR, FDA Part 820 and ICH GCP Guidelines.

Apply directly now, or send your updated CV to Ben Byrne at bbyrne@i-pharmconsulting.com OR (04) 21776703