• Preparing, maintaining, reviewing, and updating regulatory and technical documentation to support FDA submissions, including Pre-Submissions (Q-Subs) and preparation, coordination, and participation in FDA meetings • Acting as a primary regulatory interface for communication with the FDA, including drafting, coordinating, and submitting responses to FDA inquiries within defined timelines • Preparing and supporting activities required for FDA clearance, approval, and ongoing compliance, including 510(k), DeNovo, and PMA submissions, as applicable • Supporting the development, implementation, and continuous optimization of the regulatory strategy for the US/FDA market • Working closely with the Regulatory Affairs team in Vienna to ensure alignment between US and global regulatory activities • Coordinating regulatory activities with our US-based regulatory consultant and internal cross-functional stakeholders • Ensuring a thorough understanding and correct interpretation of FDA regulations applicable to in vitro diagnostic medical devices, with a strong focus on multiplex tests • Supporting internal and external audits, FDA inspections, and regulatory reviews, including preparation of documentation, follow-up actions, and responses • Contributing to post-market surveillance, change management, and life-cycle activities, as well as the preparation and maintenance of SOPs, work instructions, and templates, where relevant

• Assisting with the build out of compliance matrices for new jurisdictions including but not limited to identifying risk owners, detecting and implementing controls, and establishing responsibilities to ensure regulatory requirements are met • Manage the preparation, review, and submission of reports to internal and external stakeholders, including regulators, and other relevant parties, ensuring accuracy, timeliness, and compliance with applicable standards and requirements • Undertaking compliance monitoring reviews including obtaining evidence of compliance and working with the business on any areas of non-compliance and generating regular and routine reports on the same to management • Undertaking regulatory filings as required by gaming licenses or applicable law • Updating the wider compliance team on developments in gaming legislation and other laws impacting the operation on a gaming business • Assisting Compliance Manager provide advice to the business teams regarding all areas of regulatory compliance including advising on marketing promotions and campaigns • Developing and maintaining compliance guides such as policies, procedures, and manuals, as well as any other documents necessary to meet internal and external requirements • Conduct comprehensive assessments and produce gap analysis reports to ensure regulatory compliance • Conduct risk assessments to identify potential compliance risks and ensure that related training programs and control measures are effectively designed and implemented to address identified risks and meet the company’s needs • Collaborate with internal teams to ensure company policies are appropriately implemented by conducting investigations, developing improvement plans, and implementing corrective actions to address compliance-related issues • Any other job-related duties as assigned

• Overseeing the design, execution, and improvement of the company's SOX compliance program. • Managing the ICFR program and leading a team, collaborating with process owners, and liaising with external auditors. • Ensuring regulatory adherence and enhancing internal controls while providing strategic insights into risk management. • Leading the planning, execution, and delivery of SOX business process control testing, covering both design and operating effectiveness. • Reviewing and approving business process documentation to ensure accuracy, completeness, and audit readiness. • Ensuring the effectiveness of internal controls through a risk-based approach and maintaining compliance with the COSO framework. • Managing SOX program timelines and key milestones, coordinating activities across teams for timely delivery. • Partnering closely with business process owners and external auditors, supporting control design and execution.

• Advise on regulatory requirements applicable to our product • Guide development of compliance-related product features • Review product roadmap through a compliance lens • Support creation of compliance framework and best practices