• Support and maintain the Crypto.com Compliance Program to include: Bank Secrecy Act/Anti-Money Laundering (BSA/AML), policy development, procedure maintenance, and ongoing monitoring • Support audits and reviews of the AML compliance program; engage with internal stakeholders to facilitate issue resolution • Assist in the development and management of project plans for regulatory remediation efforts, including scope, timelines, resources, and deliverables • Coordinate with internal teams and external consultants to facilitate remediation efforts and communicate progress to relevant stakeholders • Prepare materials for working groups, committees, project dashboards, and executive presentations • Ensure clear and timely customer communication during the RFI process • Conduct due diligence reviews and ad hoc compliance assessments as needed • Support consumer compliance obligations, including Reg E (chargebacks, notice requirements, prepaid card and credit card compliance) and UDAAP • Own and maintain compliance policies and procedures, keeping them current with regulatory changes and business developments • Identify procedural opportunities and help drive process improvements across the compliance function • Perform ad hoc special projects as required • Work with regulators and help facilitate regulatory relationships as needed

Role Description We are seeking a Regulatory Affairs Specialist that will lead and perform regulatory submission/approval activities for the company’s medical device products as directed with primary responsibility for FDA. This individual will provide clinical study regulatory support, some international (outside North America) regulatory submission support, coordinate with FDA and international regulators on submission reviews and approvals and ensure compliance with required regulations and established corporate standards. - Define regulatory requirements necessary for regulatory approval of products in North America. - Complete North American regulatory assessments as required to support projects and provide direction to project teams to support new product development and product modifications as required. - Provide direction on application of external standards for all projects as required. - Maintain all regulatory documentation to ensure availability for audits and preparation of submission packages for North America. - Lead regulatory activities for product field corrective actions to maintain compliance and ensure that product approvals are properly maintained, and product re-submissions are properly managed. - Assist in the development and implementation of required post-market surveillance. - Maintain all regulatory documentation to ensure availability for audits and preparation of submission packages for international markets. - Coordinates timely renewal of certificates, licenses, and registrations. - Assist in creation of product labeling and instructions for use [package inserts] by collaborating with cross-functional business partners. - Review and approve marketing literature and other items for compliance with relevant regulatory requirements. - Assist in the development and implementation of the Physician Payments Sunshine Act. - Author, review, and/or approve internal operating procedures related to regulatory affairs. - Knowledge of Quality Systems Manual, Product Development, QSR & MDD, Complaint Handling. Qualifications - A bachelor's degree in a science or engineering concentration is required. - Minimum of 5 years of experience in Regulatory Affairs. - Requires 5+ years' medical device industry experience including authoring PMA, IDE, and 510(k) submissions, preferably in the cardiovascular field. - Experience with Class III devices required. - Experience with Health Canada and international market submissions a plus. - Strong working knowledge and experience with quality systems regulations and guidelines, ISO 13485, GMP, Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR) and FDA regulatory requirements. - Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel. - Demonstrated ability in project management skills in order to plan, conduct and implement system assessments and robust submissions. - RAC Certification preferred. - Microsoft Office software experience. Requirements - Leadership: Foster teamwork, lead courageously, champion change. - Motivation: Drive for results, work commitment. - Self-Management: possess integrity, exhibit honesty, demonstrate adaptability. - Interpersonal: value diversity, develop relationships. - Communication: communicate openly, listen to others. - Thinking: demonstrate sound judgment, assess strategically, analyze issues. Benefits - Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies. - Collaborative and dynamic work environment with a culture of innovation and excellence. - Competitive compensation package, including salary, performance-based bonuses, and stock options for full-time employees. - Career development opportunities and a chance to be part of a growing company that values its employees.

• Lead risk management for abstraction licence changes across AMP programmes, including WINEP and TLL • Maintain a central record of proposed licence changes, tracking drivers, risks, dependencies, and mitigations • Monitor progress and emerging risks, ensuring timely escalation and intervention where required • Identify when abstraction caps cannot be met and lead the development of robust Public Interest Cases (IROPI / OPI) • Engage proactively with regulators, consultants, and internal teams to secure outcomes that protect water supplies and enable compliance • Collaborate with the Sustainable Abstraction Programme Team to design environmental mitigation and compensatory measures • Shape and influence long ‑ term sustainable abstraction strategy, including innovative approaches such as dynamic abstraction licensing • Ensure abstraction needs and licence caps are fully and accurately reflected in WRMP29, PR29, and wider environmental programmes • Provide strategic insight on emerging regulatory trends, risks, and opportunities • Influence future regulatory direction through proactive engagement and policy shaping • Manage consultant support to deliver technical, regulatory, and evidence ‑ based case development • Champion a strong health, safety, and continuous improvement culture

• Operate with proficiency across compliance functions, owning projects end-to-end and helping advance the maturity and effectiveness of our enterprise compliance program. • Serve as a trusted advisor to internal stakeholders and clients. • Identify, assess, and mitigate risk across the organization. • Build dashboards, metrics, and workflows to improve compliance processes. • Mentor junior staff and building team capability through functional expertise and project leadership. • Communicate expectations across all divisions; establish and integrate best practices.