Role Description At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry. To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing laws, regulations, and public policies across the globe. In this context, we are looking for regulatory affairs experts in the med-tech space to play a key role in driving Oracle's success and competitiveness in the healthcare and life sciences sector. - Work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device). - Help prepare the required documentation to register products in global markets where the products are sold. - Establish strong partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch to post-market activities of software products in scope. - Define regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance (e.g. advertising/promotion, etc.), as applicable. - Work primarily with the Oracle Health & Life Sciences business units but will also interact with all Oracle business units selling products to the health and life sciences industries. - Seek a regulatory strategist who is collaborative, a creative problem solver, and dedicated to excellence in their work. Position is opened at the principal level, for 10+ years of experience. One level lower (senior) and one level higher (lead) will also be considered. Qualifications - BA/BS or advanced degree preferred. - Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. - Experience authoring submissions (510k, EU Tech Files, etc.) required. - Experience with sustaining and new product development is ideal. - Experience interacting with notified bodies and/or regulators preferred. - RAC, CQE, CPPS, CQA desired. - Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001, or Quality System Regulations. - Understands continual improvement and risk management. - Excellent written and verbal communication skills. - Ability to adjust and adapt to changing priorities in a dynamic environment. - Ability to perform in a fast-paced and continually evolving business environment. Benefits - Flexible medical options. - Life insurance. - Retirement options. - Encouragement for employees to give back to their communities through volunteer programs. Company Description Oracle's Healthcare and Life Sciences business is a global leader in industry-specific software and solutions to healthcare providers, payers, pharmaceutical companies, medical device companies, and clinical research organizations. We offer a range of products and services, including AI/ML solutions, cloud-based healthcare platforms, data analytics, electronic health records (EHR), and patient engagement systems. The business aims to help organizations improve patient outcomes, lower costs, and accelerate innovation. By leveraging Oracle's technology and expertise, healthcare and life science organizations can streamline their operations, gain insights from data, and make more informed decisions. Oracle also enables secure and compliant handling of sensitive healthcare data, helping organizations meet regulatory requirements and protect patient privacy. With a focus on digital transformation, Oracle's Healthcare and Life Sciences business empowers the industry to embrace modern technologies and improve overall healthcare delivery.

• Perform ongoing clinical data review to ensure data quality, consistency, and completeness • Identify discrepancies and raise/resolve queries in EDC systems • Review patient data including eligibility, medical history, treatment, safety data, and outcomes • Contribute to and follow the Data Review Plan (DRP) • Cross-check data across multiple sources (e.g., EDC, labs, safety databases) • Support data cleaning activities ahead of interim analyses and database lock • Collaborate with Clinical, Data Management, and Operations teams to resolve data issues • Monitor site data entry performance and escalate risks or delays • Participate in study meetings and provide status updates on data review activities • Ensure compliance with GCP, protocols, and regulatory requirements

• Identify errors in data through data review • Perform ongoing review of clinical participant data • Issue and follow up on clinical data queries • Monitor site data entry performance • Collaborate with clinical teams for data review

Title: Clinical Reviewer - (Remote) Location: United States Job Description: Remote Working time Full-time Description & Requirements Maximus is hiring a Clinical Reviewer to support the Illinois SALT program. The Clinical Reviewer is responsible for evaluating assessments and making determinations regarding individuals' needs for additional supports and services. This role includes conducting quality control reviews of field assessors' work to ensure accuracy and compliance. Training Schedule: - Monday to Friday, 8:00 AM – 5:00 PM CST Post-Training Work Schedule: - Thursday to Sunday, 8:00 AM - 6:30 PM CST About the program We have contracted with the State of Illinois Department of Healthcare and Family Services (HFS) to manage the assessment process for Preadmission Screening and Resident Review (PASRR) Level I screens and completing Level II Serious Mental Illness (SMI) evaluations for individuals applying to, or residing in, Medicaid-certified nursing facilities. Other services include Follow Up Visits, admissions support for Specialized Mental Health Rehabilitation Facilities (SMHRF) and Supported Living Programs (SLP) settings and Colbert Dementia Review. Continues to expand assessment services in the state. Why Maximus? - Work/Life Balance Support - Flexibility tailored to your needs! - Competitive Compensation - Bonuses based on performance included! - Comprehensive Insurance Coverage - Choose from various plans, including Medical, Dental, Vision, Prescription, and partially funded HSA. Additionally, enjoy Life insurance benefits and discounts on Auto, Home, Renter's, and Pet insurance. - Future Planning - Prepare for retirement with our 401K Retirement Savings plan and Company Matching. - Paid Time Off Package - Enjoy PTO, Holidays, and extended sick leave, along with Short and Long Term Disability coverage. - Holistic Wellness Support - Access resources for physical, emotional, and financial wellness through our Employee Assistance Program (EAP). - Recognition Platform - Acknowledge and appreciate outstanding employee contributions. - Tuition Reimbursement - Invest in your ongoing education and development. - Employee Perks and Discounts - Additional benefits and discounts exclusively for employees. - Maximus Wellness Program and Resources - Access a range of wellness programs and resources tailored to your needs. - Professional Development Opportunities-Participate in training programs, workshops, and conferences. Essential Duties and Responsibilities: - Review requests for services including admission, discharges and continued stays for adherence to clinical criteria, state and federal policy, and related requirements. - Issue approvals, denials or recommendations based on contract requirements. - Identify need for additional clinical documentation or consultation. - Complete documentation of activities within contract systems. - Communicate with providers, individuals and their designees, or state workers as required. - Performs other related duties as assigned. Required Skills/Abilities: - Preferred knowledge may include community support programs, long-term care assessment and level of care in medical, behavioral health or related programs - Knowledge and understanding of medical and/or behavioral health diagnoses and prescribed medications - Ability to collect data, define problems, establish facts, and draw valid conclusions Minimum Requirements - Education and licensure requirements are based on program contract requirements and are outlined in job posting - High School Degree or equivalent required - Minimum 1 year of clinical experience required - Master’s Degree in Social Work, Mental Health or related degree program - Minimum of two (2) years post-graduate work experience in the mental health field - Minimum of two (2) years experience conducting mental health assessments - Proficiency in Microsoft office Applications Preferred Requirements: - Demonstrates outstanding interpersonal and verbal communication skills - Demonstrates strong proficiency in written communication, producing concise and impactful documentation - IM+CANS certification or willingness to obtain IM+CANS certification - Strong computer skills - Knowledgeable about PASRR Home Office Requirements: - Maximus provides company-issued computer equipment - Reliable high-speed internet service - Minimum 20 Mbps download speeds/50 Mbps for shared internet connectivity - Minimum 5 Mbps upload speeds - Private and secure workspace #ClinicalServices #LI-Remote EEO Statement Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics. Pay Transparency Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Accommodations Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process—including accessing job postings, completing assessments, or participating in interviews,—please contact People Operations Minimum Salary $ 25.07 Maximum Salary $ 30.67