• Data steward of regulatory data in the RIM system (e.g., enter, update, and maintain), ensuring accuracy, completeness, and timeliness • Create, archive, and maintain regulatory submissions, Health Authority correspondence, and Health Authority commitments within the RIM system, in accordance with internal standards • Maintain submission trackers, timelines, track submission history and Health Authority commitments to ensure visibility into milestones • Coordinate with cross-functional teams and Regulatory Operations to support US submission planning, compilation, and timely delivery of regulatory documentation • Support preparation and organization of regulatory submission components (e.g., INDs, CTAs, amendments) • Perform QC activities (including eCTD QC for US submissions, as appropriate) to ensure completeness, consistency, and technical readiness • Support inspection readiness activities (e.g., TMF health checks, document completeness reviews) • Support department meetings and cross-functional communication, including agenda development, coordination of materials, and documentation of outcomes

Role Description The Regulatory Affairs Director is responsible for overseeing, developing, and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory clearance and approval for the Diality products. This position is also responsible for supporting the Quality Management System and will serve as the Regulatory Affairs lead on product teams. The Regulatory Affairs Director will also act as the Regulatory Responsible Person as defined by the EU MDR. - Develops regulatory strategic plans and provides support to ensure adherence with global regulatory requirements. - Plans and prepares regulatory submissions for new products and product changes, including: - US FDA Investigational Device Exemption (IDE) - US FDA 510(k) - CE Marking under EU MDR - Product amendments to existing regulatory approvals/clearances - Serves as the primary contact with US Food and Drug Administration (FDA) and liaises with other country Regulatory Agencies. - Represents Diality in cross-industry regulatory initiatives. - Responsible for obtaining and maintaining: - Local, State and National Regulatory licensing and registration renewals - Import/Export Permits - Assesses product and manufacturing changes and develops regulatory assessments for each market. - Provides assistance and regulatory guidance regarding product labeling, marketing materials, and social media. - Provides oversight for Regulatory processes and systems. - Supports Quality System projects and activities, including: - Complaint Handling - Post-market vigilance and clinical follow-up activities. - Leads inspections/audits by the notified body or other international regulatory Agencies. - Participates in and reviews risk management activities/documents to ensure compliance with ISO 14971. - Maintains a “big picture” perspective, taking personal responsibility for actions and maintaining a commitment to regulatory compliance, quality, ethics, and integrity. Qualifications - Demonstrated excellence in developing global regulatory affairs strategies for medical products. - Broad-based technical knowledge and skills in diverse areas of business such as Engineering, Operations, Quality, Marketing, Clinical Research, etc. - Ability to effectively negotiate and influence cross-functional stakeholders, affiliates, and Regulatory authorities. - Proven track record of maintaining regulatory knowledge and skills by participating in industry conferences/seminars. - Comprehensive knowledge of laws and regulations applicable in an FDA-regulated environment. - Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations. - Good knowledge of clinical evaluation and investigation of medical devices. - Excellent interpersonal skills including ability to interact with a high degree of diplomacy. - Excellent problem-solving, applied thinking, and technical writing skills. - Excellent communication and organization skills required. - Ability to work in a fast-paced, technically challenging environment. - Expertise in Microsoft Office and Adobe Acrobat applications. - Familiarity with dialysis and end-stage renal disease is a plus. Requirements - Minimum science or engineering BS degree with at least 10+ years of medical device regulatory affairs experience or a Regulatory Affairs MS or PhD with at least 7+ years of medical device regulatory affairs experience. - Certification in regulatory affairs (RAC) preferred. - 2+ years of Regulatory Affairs leadership in a small/start-up company environment. - Previous experience interacting directly with FDA is required. - Experience reviewing and approving technical documentation. - US and EU medical device regulatory submission experience required. - Hands-on experience with 510(k) and Technical File/Design Dossier submissions. - Product development team experience. Travel - Ability to travel (domestic and international) as required, approximately 10%. Physical Requirements - Prolonged periods of sitting at a desk and working on a computer. - May be expected to lift 15 pounds at times. Working Environment - Office or work-station environment. - Remote work environment is also an option for this position.

• Managing the maintenance and expansion of compliance programs • Ensuring policies, practices, and procedures are understood and followed • Responsible for State and Federal regulatory compliance in consultation with teams • Providing subject matter expertise for FedRAMP and NIST 800-53 compliance standards • Owning management and execution of the external audit calendar • Leading the completion of corrective and preventive actions for audits • Ensuring systems vulnerability and penetration tests are executed and results communicated • Conducting continuous monitoring reporting and annual reviews of System Security Plans • Assisting in business process improvements and partnering with stakeholders • Collaborating to drive, track, and resolve Compliance readiness and audits • Assisting with forecasting, planning, and risk assessment relevant to compliance program • Maintaining industry knowledge and best practices • Project management including analysis of requirements, updating project plans, and tracking projects • Mentoring and cross-training team members • Developing metrics and dashboards for reporting on Regulatory Compliance programs

• Support day-to-day activities for Rapid7’s US Public Sector compliance programs, with a primary focus on FedRAMP • Assist in maintaining compliance documentation, including policies, procedures, system security plans (SSPs), authorization artifacts, and supporting evidence • Support continuous monitoring (ConMon) activities, including ongoing evidence collection and reporting • Assist in managing Plans of Action & Milestones (POA&Ms), including tracking remediation progress, timelines, and risk ownership • Track and support control implementation aligned to NIST 800-53 rev. 5 and NIST 800-171 • Use ATO-focused GRC platforms such as Paramify, ServiceNow GRC, Onspring, or RegScale to manage compliance status, risks, and findings • Partner with Engineering and Security teams to understand technical control implementations, vulnerabilities, and remediation plans • Support audit and assessment readiness activities, including ATO packages and regulatory reporting • Assist with vendor reviews, including Control Implementation Summaries (CIS) and Customer Responsibility Matrices (CRM) • Help identify opportunities to improve GRC, POA&M, and ConMon processes through standardization, automation, and improved data quality • Gain hands-on exposure to evolving requirements such as CMMC, new Executive Orders, and emerging US public sector cybersecurity initiatives