• Oversee regulatory affairs workstreams, ensuring deliverables meet quality and timeline expectations • Lead the preparation, submission, and maintenance of Clinical Trial Applications (CTAs) and Investigational New Drug (IND) applications • Develop and implement regional clinical trial regulatory strategies • Provide strategic input to clinical study teams and Global/Regional Regulatory Leads (GRL/RRL) • Collaborate closely with the Clinical Trial Unit RA, Early Development, Clinical Operations, and Global Regulatory Affairs • Prepare, review, and ensure the quality, scientific integrity, and regulatory compliance of technical and administrative documentation • Monitor and interpret changes in clinical trial regulations • Support regulatory inspections, audits, and compliance activities related to clinical trial conduct and documentation • Provide mentorship and regulatory guidance to internal stakeholders

• Lead end-to-end third-party risk management (TPRM) lifecycle: Due diligence and onboarding, Risk tiering and assessments, Contractual risk controls, Ongoing monitoring and offboarding • Manage a team of risk analysts who: Evaluate risks associated with vendors, partners, and outsourced services, including financial, operational, compliance, and reputational risks, Conduct risk management for external websites and mobile applications, Support additional risk assessments as required • Partner with other corporate teams to: Review security controls, vulnerabilities, and penetration testing results, Ensure data protection, privacy, and resilience standards are met, Drive a strong risk culture, ensuring accountability across first, second, and third lines of defense • Mature and improve the program: Integrate third-party risk into broader enterprise risk and operational risk frameworks, Distribute assessment assignments and monitor progress to ensure SLAs are met across all risk levels, Support quality assurance by reviewing assessment documentation and identifying areas for process improvement, Track team metrics, backlog status, and stakeholder engagement levels for reporting, Lead team standups and serve as the primary point of contact for operational blockers or intake escalations, Identify opportunities for efficiency improvements, automation, and stakeholder engagement enhancements

Role Description Reporting to the Senior Manager, Clinical Compliance, the Specialist, Clinical Compliance supports the operational execution of JenaValve’s clinical compliance program. Responsibilities span: - Audit logistics and documentation - CAPA and non-conformance tracking - Vendor qualification recordkeeping - SOP coordination - Training administration - Compliance metrics reporting The role requires independent judgment, strong organizational skills, and effective collaboration across Clinical Affairs sub-departments. Qualifications - 2+ years in clinical research, clinical operations, or clinical quality assurance; medical device experience strongly preferred. - Bachelor’s degree or higher in life sciences, health sciences, or a related field required. - Working knowledge of ICH E6 GCP guidelines and FDA regulations applicable to medical device clinical trials; familiarity with ISO 14155 preferred. - Prior experience supporting clinical audit activities, document control, or compliance tracking is a significant advantage; cardiovascular or structural heart experience is an advantage. - Strong organizational skills and attention to detail; ability to manage multiple concurrent tracking responsibilities with accuracy in a fast-paced environment; excellent written and verbal communication skills. Requirements - Demonstrated ability to manage complex tracking systems across multiple work streams with high accuracy; strong Excel skills; familiarity with eTMF and document control systems. - Strong critical thinking and independent judgment; able to identify compliance gaps, prioritize follow-up, and escalate appropriately; ability to collaborate and influence effectively across a multi-functional organization. - Excellent written and oral communication skills; ability to produce clear compliance summaries, tracking reports, and procedure documents; proficient in Microsoft Office Suite; CTMS and EDC experience an advantage. Benefits - Standard office environment requirements. - Minimal travel, up to 10%.

Role Description Reporting to the Vice President, Clinical Affairs, the Senior Manager, Clinical Compliance owns the clinical compliance program for JenaValve’s active clinical studies. This includes: - Audit program (internal and investigational site) - Vendor qualification and quality oversight - Department procedure lifecycle - Regulatory intelligence - Internal training The role works in close partnership with the Quality organization to ensure alignment on quality systems, audit scheduling and conduct, and CAPA processes, serving as the primary compliance bridge between Clinical Affairs and Quality. This individual directly manages the Specialist, Clinical Compliance. Qualifications - 7+ years in clinical research, clinical operations, or clinical quality assurance; medical device experience strongly preferred. - Minimum 3 years dedicated GCP audit or clinical compliance experience; demonstrated experience as a lead auditor conducting both site and vendor/CRO audits required. - Bachelor’s degree or higher in life sciences, health sciences, or a related field required; advanced degree preferred. - Thorough knowledge of ICH E6(R3), FDA regulations (21 CFR Parts 11, 50, 54, 56, 812), and ISO 14155; demonstrated SOP authorship and procedure lifecycle management experience. - Prior people management experience; ability to lead and develop direct reports in a fast-paced, growing organization. - Cardiovascular or structural heart therapeutic area experience is a significant advantage. Requirements - Develop and execute a risk-based audit program covering internal processes and investigational sites. - Own CAPA and non-conformance management for the department. - Own the vendor qualification and ongoing quality oversight program for CROs, core labs, EDC vendors, and other clinical service providers. - Lead the Clinical Affairs procedure lifecycle, including authoring, reviewing, and approving SOPs and work instructions. - Monitor and communicate regulatory developments and GCP guidance updates (FDA, ICH, EU CTR). - Design and deliver the Clinical Affairs internal training program. - Directly manage and develop the Specialist, Clinical Compliance. - Support continuous process improvement and PMA/IDE activities as they relate to compliance. Benefits - Standard office environment requirements. - Travel up to 25%, primarily for investigational site audits, vendor audits, clinical meetings, and periodic home office visits.