• Authoring and reviewing regulatory submissions, including INAD filings, study reports, clinical trial evaluability meetings, and agency correspondence • Leading preparation for FDA CVM meetings, including  briefing documents, meeting requests, posing questions, and follow-up MOCs • Partnering with clinical teams to provide real-time regulatory guidance on active studies, including SAE submissions, BIMO preparedness, and NCIE reports • Reviewing and preparing study protocols, ICFs, and amendments to ensure the highest quality submissions for pivotal protocol concurrence • Monitoring and interpreting CVM guidance, policy updates, and precedent to inform Loyal's regulatory strategy across our pipeline • Anticipating and resolving regulatory risks across functions (including R&D, CMC, and commercial) throughout the portfolio before they become problems • Managing and mentoring 1–2 direct reports, providing feedback, priorities, and development support • Collaborating cross-functionally with R&D, clinical development, clinical operations, data management, and legal teams on submissions and strategy • Oversee the maintenance and organization of all regulatory records and interactions related to Loyal’s drug programs • Serving as the internal subject matter expert for any question touching FDA CVM clinical requirements — from study design to labeling to adverse event reporting  • Reviewing and advising on external facing pre-approval communications and activities to ensure compliance with FDA CVM regulations • Reviewing and providing guidance on labeling materials for submission to ensure compliance with FDA CVM regulations

About PracticeTek Stop scrolling-your dream job might just be here! At PracticeTek, we don’t do ordinary, we do bold ideas, big impact, and endless opportunities to grow. Imagine working with teammates who celebrate your wins, challenge you to think bigger, and cheer you on every step of the way. Imagine building solutions that actually change lives and reshape how healthcare works. That’s the vibe here: high-energy, high-impact, and 100% human. Ready to jump in? Let’s go! We’re on a mission to revolutionize healthcare practices effortlessly and we live out our brand promise every day: being the Trusted Partner in retail healthcare. PracticeTek is one of the largest retail-healthcare tech providers in North America, offering everything a practitioner would need, from pre-encounter workflows to practice management, analytics, digital intake forms, marketing tools, EHRs, and payment systems, for a whopping 40,000+ clinics worldwide. Over the years, we’ve brought together the best-in-class platforms that serve the Chiropractic, Wellbeing, Vision and Dental providers and their patients; and we are united by one mission, to revolutionize retail healthcare practices effortlessly. Here, you’ll have the flexibility to contribute across multiple brands, each offering a unique path for growth. Whether you’re building products, supporting customers, or driving strategy, your journey with PracticeTek is full of opportunity. We believe in showing up with consistent care, staying always ahead, keeping our approach market-in, making every experience feel effortless, owning it openly, and striving to do right in every decision. These aren’t just words; they’re how we live, work, and make an impact together. At PracticeTek, you’ll get to: Shape the future of healthcare with technology solutions that are always evolving to meet real-world needs. Team up with passionate, talented people who care deeply about patients, providers, and making a difference. See your impact firsthand by helping practices deliver care that’s simpler, smarter, and better for everyone. Grow your career and your skills in an environment that celebrates curiosity, collaboration, and continuous development. We’re excited to consider remote candidates for this role! That said, if you’re based in Las Vegas, NV; Green Bay, WI; or San Diego, CA, you’ll enjoy a dynamic hybrid setup. spending three days each week collaborating in the office and the rest working from wherever you’re most productive. Why You’ll Love It Here As part of the TekTribe, you’ll enjoy: Comprehensive health, dental, and vision coverage options Wellness benefits that support lifestyle, behavioral health, and overall wellbeing Flexible paid time off, sick time, and 10 company-paid holidays 401(k) plan with company match to help you build your future Culture Committee driving initiatives that spark connection, fun, and belonging A workplace powered by innovation, collaboration, and energy every day What You’ll Do Here’s how you’ll help us bring our mission to life and show up as a Trusted Partner: - Perform risk-based reviews of merchant applications, validating data accuracy, completeness, and compliance with PayFac and processor requirements prior to onboarding - Conduct KYC, OFAC, and beneficial ownership verification, identifying discrepancies, fraud indicators, and documentation gaps that require resolution before approval - Monitor merchant portfolios post-onboarding, analyzing transaction behavior, chargebacks, and processing trends to proactively identify emerging risk - Recommend and support risk mitigation actions (e.g., reserves, holds, account reviews) to protect the business from financial and regulatory exposure - Partner cross-functionally with Payments, Support, and Operations to resolve merchant issues, communicate requirements, and ensure a seamless onboarding and funding experience How Success is Measured Here’s how we’ll know you’re making an impact and raising the bar: - High accuracy and completeness of merchant application reviews - Timely completion of onboarding and risk reviews in alignment with established SLAs - Effective identification and escalation of risk signals to minimize fraud and chargeback exposure - Strong satisfaction from merchants and internal stakeholders through clear, responsive communication - Consistent maintenance of accurate and up-to-date records across systems What You Bring Your unique talents are what make you shine. For this role, success looks like: Required Qualifications - 2–4 years of experience in payments risk, merchant onboarding, PayFac, or acquiring environments - Working knowledge of KYC, OFAC, and FinCEN requirements, with the ability to follow established compliance and onboarding processes - Foundational understanding of chargebacks, merchant funding, and settlement flows - Strong analytical and detail-oriented mindset, with the ability to assess information accurately and exercise sound risk judgment - Ability to manage a high volume of reviews while maintaining accuracy and meeting SLAs - Experience using tools such as Salesforce and Excel to manage and track merchant data - Clear written and verbal communication skills, with the ability to work effectively with internal teams and external merchants Preferred Qualifications - Experience in a PayFac model with exposure to both merchant underwriting and ongoing risk monitoring - Demonstrated ability to assess merchant risk, including evaluating business models, transaction behavior, and supporting documentation - Experience identifying and escalating risk signals such as unusual processing patterns, excessive chargebacks, or documentation discrepancies - Familiarity with implementing or supporting risk mitigation actions (e.g., reserves, holds, account reviews) - Experience working in a fast-paced, high-growth SaaS or fintech environment Ready to Join? If you’re excited to bring your ideas, energy, and expertise to a team that’s shaping the future of healthcare, we can’t wait to hear from you. Apply today and let’s make healthcare simpler, smarter, and Better. Together. The Fine Print (That Really Matters) At PracticeTek, we determine compensation by considering market data, internal equity, and each candidate’s skills and experience. For this position, we reasonably expect to pay between [Salary Range entered in by TA]. This role is also eligible for benefits, including health, dental, vision, paid time off, 401(k) with company match, and may be eligible for additional compensation such as bonuses or equity, as applicable. PracticeTek is an Equal Opportunity Employer. We are committed to creating an inclusive environment where all employees feel valued and supported. All qualified applicants will receive fair treatment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, age, disability, veteran status, genetic information, marital status, uniformed service status, or any other characteristic protected under applicable law. This job description is not a contract of employment and does not alter the at-will relationship between PracticeTek and its employees.

• Collect, manage, and maintain all data and statistics required for compliance with SART regulations • Stay current on all SART guidelines and implement updates as requirements evolve • Collaborate with nursing and embryology teams to ensure accurate and timely data entry into Resource/FERT and other reporting systems • Coordinate and report all required data and outcome statistics to meet New York State regulations related to donor egg and donor sperm use in IVF and IUI • Ensure compliance with four-day prospective reporting requirements to SART • Accurately close ART cycles and report outcomes in accordance with SART standards • Maintain adherence to SART, CDC, and NASS (National ART Surveillance System) guidelines, ensuring timely and accurate reporting • Prepare and submit delivery outcome requests to clinical teams based on practice needs • Provide administrative support to the VP of Nursing and Clinical Services • Obtain and distribute laboratory reports requested by clinical staff • Manage the Prescription Monitoring Program (PMP) Registry, including entering all controlled substance prescriptions on a daily basis and responding to New York State inquiries regarding patient prescriptions • Oversee the WIN Fertility Patient Portal and treatment outcomes processes, including receiving and routine treatment request forms to patient coordinators, completing treatment outcome forms as requests, and partnering with the Finance team to ensure accurate billing • Coordinate Progyny treatment outcome requests and provide necessary medical records to the Progyny coordinator • Support additional clinical compliance projects and initiatives as needed

• Represent the Company before the Spanish local authorities (Bank of Spain, SEPBLAC). • Responsible for all regulatory activities related to our Spanish license, through which the company provides services throughout all the EEA. • Help the GHC in ensuring that implementation of the various local compliance programs is risk-based, efficient and consistent with the groupwide regulatory compliance framework. This includes drafting and maintaining global and local policies and processes. • Coordinate internally and support the GHC in the implementation of regulatory programs, fundamentally at EEA and UK level (e.g. DORA, Operational resilience, Consumer Duty, Fraud prevention, AML, Sanctions etc.). • Report to internal governance bodies on matters related to the group regulatory compliance framework and on Spanish local regulatory exposure. • Arrange processes to assure that the regulatory compliance policies in place are well understood and respected by relevant employees and that the company is complying with all regulatory requirements everywhere it operates. • Work alongside the Head of Global Operational Compliance to ensure close alignment. • Subject matter expert on Regulatory Compliance for Spain.