• FDA 510(k) submission • Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality, and regulatory compliance • Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents) • Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format, • Lead submission lifecycle activities, including: Acceptance Review support (RTA readiness) • Substantive Review coordination • Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications • Updating submission content and modules as required • Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process. • Provide regulatory leadership through FDA clearance. • EU MDR Technical Documentation Support • Conduct EU MDR readiness assessment aligned with Notified Body expectations and conformity assessment requirements. • Perform critical review and gap analysis of EU MDR technical file • Provide targeted recommendations to ensure audit-readiness and Notified Body acceptance • Lead or support submission to obtain CE Mark.

• You'll own compliance and internal quality assurance across our operations — building the systems and processes that ensure we stay compliant across markets and partners in a scalable, effective way. • You'll consult our Solutions team during the conception of new markets, shaping requirements from the ground up, then take full ownership within Operations to enforce, oversee, and continuously improve them. • This means translating regulatory requirements into robust frameworks, conducting internal audits, and ensuring our operational processes consistently meet the bar we set. • Build, implement, and continuously improve our Quality Management System (QMS), including SOPs, process documentation, and document control standards • Plan and conduct internal audits of our operational processes, driving corrective and preventive actions to ensure we consistently meet our own bar • Consult our Solutions team during the conception of new markets and partner setups, helping shape compliance requirements from the ground up • Take full ownership of enforcing and overseeing those requirements within Operations — qualifying, auditing, and monitoring recycling and collection partners against our quality and regulatory standards • Define and manage partner governance processes, including supplier audit cycles and remediation tracking • Monitor regulatory developments across active markets and ensure we stay ahead of compliance obligations in a scalable, structured way • Own all documentation required for ISO certifications, insurers, enterprise customers, and external audits • Serve as the go-to expert for quality and regulatory topics across the organization

QC and Compliance Senior Manager, Tax Operations Location: Atlanta, GA / Boston, MA / Asheboro, NC / Birmingham, AL / Charlotte, NC / Greensboro, NC / Fort Lauderdale, FL / Mooresville, NC / Mount Airy, NC / Needham, MA / Philadelphia, PA / Raleigh, NC Tax - Tax Operations Full Time Hybrid Job Description Work with a Top 20 CPA and advisory firm that Accounts for Anything. Aprio has 40 U.S. office locations, as well as international office locations and more than 3,200 team members that speak 60+ languages across the globe. By bringing together proven expertise, deep understanding, and strategic foresight for fast-growing industries, Aprio ensures clients are prepared for wherever life or business may take them. Discover a top-rated culture, vast growth opportunities and your next big career move with Aprio. Join Aprio''s Tax Operations team and you will help clients maximize their opportunities. Aprio Advisory Group, LLC is a progressive, fast-growing firm looking for a QC & Compliance Senior Manager to join their dynamic team. The QC & Compliance Senior Manager is responsible for quality control and compliance oversight for the Centralized Returns Teams. This role leads initiatives to improve accuracy, efficiency, and automation across centralized processing, delivery, and e-filing, while ensuring timely and clear communication to the practice around due dates and system updates. Responsibilities: - Design, implement, and continuously improve QC and compliance processes for centralized processing, delivery and e-file teams. - Collaborate with Manager of Centralized Returns to manage the centralized teams process and team members. - Monitor team performance and establish metrics, dashboards, and routines to identify trends and drive corrective actions. - Forecast volumes of returns coming to centralized teams and share proactive capacity/throughput insights with stakeholders. - Troubleshoot, address and resolve escalated issues - Coordinate essential due-date communications to the practice - Stay up to date on filing due date changes and tax software updates. - Partner with technology/development teams to identify, prioritize, and deliver automation opportunities to improve accuracy and efficiency of centralized teams. - Review workflows and revise when needed to standardize and processes - Develop and maintain a contingency plan for the weeks leading up to major due dates, including escalation paths, surge capacity, and communication cadence. - Drive innovation and creative solutions to improve efficiency and responsibly expand offshore leverage and seasonal staffing models. - Support organizational planning for centralized teams, including restructuring recommendations aligned to operational goals. Qualifications: - Demonstrated experience leading QC and compliance programs in a high-volume, deadline-driven environment. - Strong process design, continuous improvement, and automation mindset. - Ability to forecast demand, translate data into actions, and manage competing priorities around peak deadlines. - Clear written and verbal communication skills; able to produce concise, essential updates for broad audiences. - Comfort partnering cross-functionally (operations, technology, and practice leadership) to deliver outcomes. - Ability to multitask and prioritize tasks effectively - Discretion and confidentiality when handling sensitive information - Detail-oriented with a commitment to accuracy - Adaptable to changing priorities and working in a fast-paced environment Why work for Aprio: Whether you are just starting out, looking to advance into management or searching for your next leadership role, Aprio offers an opportunity to grow with a future-focused, innovative firm. Perks/Benefits we offer for full-time team members: - Medical, Dental, and Vision Insurance on the first day of employment - Flexible Spending Account and Dependent Care Account - 401k with Profit Sharing - 9+ holidays and discretionary time off structure - Parental Leave - coverage for both primary and secondary caregivers - Tuition Assistance Program and CPA support program with cash incentive upon completion - Discretionary incentive compensation based on firm, group and individual performance - Incentive compensation related to origination of new client sales - Top rated wellness program - Flexible working environment including remote and hybrid options What's in it for you: - Working with an industry leader: Be part of a high-growth firm that is passionate for what's next. - An awesome culture: Thirty-one fundamental behaviors guide our culture every day ensuring we always deliver an exceptional team-member and client experience. We call it the Aprio Way. This shared mindset creates lasting relationships between team members and with clients. - A great team: Work with a high-energy, passionate, caring and ambitious team of professionals in a collaborative culture. - Entrepreneurship: Have the freedom to innovate and bring your ideas to help us grow to become the CPA firm of choice nationally. - Growth opportunities: Grow professionally in an environment that fosters continuous learning and advancement. - Competitive compensation: You will be rewarded with competitive compensation, industry-leading benefits and a flexible work environment to enjoy work/life balance. EQUAL OPPORTUNITY EMPLOYER Aprio is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race; color; religion; national origin; sex; pregnancy; sexual orientation; gender identity and/or expression; age; disability; genetic information, citizenship status; military service obligations or any other category protected by applicable federal, state, or local law. Aprio, LLP and Aprio Advisory Group, LLC, operate in an alternative business structure, with Aprio Advisory Group, LLC providing non-attest tax and consulting services, and Aprio, LLP providing CPA firm services. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

• User creation • Granting and removal of user access • Creation and modification of SAP access profiles • User management • Access profile management