• Manage process & compliance activities to implement and maintain industry best compliance and security frameworks like ISO, CSA, SSAE18 SOC, NIST, FDA, NIS, TISAX etc. • Drive consistency across QAD in maintaining compliance controls and in maintaining applicable regulatory compliance requirements in the areas of Information Security, Service Management, Risk Management, Business Continuity Management, Privacy Management, Quality Management System, etc. • Perform gap analysis for compliance standards upgrades and guide functional teams in implementing required controls, and in updating policy and procedures. • Conduct internal compliance audits and demonstrate controls during external compliance assessments. • Manage and conduct internal process and security compliance audits. • Participate in external compliance audits and present evidence and controls. • Manage customer audit requests and coordinate with the global teams in gathering and presenting evidence. • Document audit observations/findings and follow up with the impacted parties for closure of the audit findings. • Perform gap analysis for certification upgrades and implement updates. • Maintain compliance related registers like Risk, Continuous Improvements, etc. • Deliver training as required to the global teams on various compliance frameworks. • Assist business functions in performing business impact analysis and in maintaining business continuity plans. • Work with the global business functions in responding to third party questionnaires. • Proactively develop skill and knowledge on security and compliance standards and frameworks. • Stay attuned to changes in industry compliance and regulatory requirements.

• Lead regulatory strategy and execution for YUVEZZI™ including all NDA support and ongoing regulatory filings. • Manage regulatory submissions, including NDAs, DMFs, PAIs, and annual commitments for YUVEZZI™. • Develop and implement regulatory strategies to support product development, approvals, and lifecycle management. • Prepare and review regulatory documents (INDs, NDAs, DMFs, annual reports, amendments, responses to agency queries). • Lead interactions with FDA and global health authorities and partners including regulatory meetings, negotiations, and responses to inquiries. • Ensure regulatory compliance with FDA, ICH, EMA, and other global regulations. • Collaborate cross-functionally with clinical, CMC, non-clinical, and commercial teams to align regulatory strategy with business objectives. • Monitor evolving regulatory requirements and provide guidance to internal teams on potential impacts to development programs. • Represent Regulatory Affairs in strategic discussions, influencing key decisions for clinical development and commercialization as well as with licensing partners in regard to regulatory activities. • Participation as a member of the PRC committee to review commercial advertising and other similar documents.

• Serve as the primary compliance partner and advisor for MicroAire, providing practical, risk-based guidance to leadership and business functions. • Participate in MicroAire leadership forums as the primary compliance representative and help integrate ethics and compliance considerations into business planning and decision-making. • Build trusted relationships with Sales, Marketing, Medical Education, R&D, Regulatory Affairs, Quality Assurance, Human Resources, Finance, Legal, Operations, and International Business leaders. • Implement Marmon Medical Group policies, standards, and procedures at MicroAire and develop or update MicroAire-specific procedures where local operating processes are needed. • Conduct periodic compliance risk assessments for MicroAire, including interviews with leaders and key stakeholders, review of business activities, and analysis of relevant internal and external risk indicators. • Develop and deliver targeted in-person and online training for MicroAire personnel, agents, independent contractors, distributors, and other relevant third parties.

• Lead the firm's Personal Trading and Code of Ethics program, including pre-clearance, employee trading reviews, restricted list oversight, certifications, and disclosures • Serve as deputy to the VP, Compliance and Chief Compliance Officer for designated governance, regulatory, and business initiatives • Direct enterprise compliance risk assessments, annual compliance reviews, monitoring, testing, issue management, and governance reporting • Design and enhance a risk assessment framework that supports targeted monitoring, testing, and remediation activities • Manage, coach, and develop a team of compliance professionals while fostering a culture of accountability, collaboration, and continuous improvement • Partner with business leaders and control functions to provide guidance on regulatory requirements, conflicts of interest, fiduciary obligations, and supervisory expectations • Lead regulatory examinations, internal audits, and annual reviews, coordinating responses and remediation efforts • Present compliance reporting, trends, and recommendations to senior leadership, governance committees, and boards • Monitor regulatory developments and implement enhancements to policies, procedures, controls, and compliance programs • Sponsor technology, automation, analytics, and AI-enabled compliance capabilities that strengthen surveillance, reporting, and operational effectiveness