Role Description The Office of Human Subjects Research is seeking a Human Research Compliance Associate to provide regulatory and compliance advice to the Johns Hopkins University Institutional Review Boards (JHU IRBs). This includes applicable federal, state, and local laws and regulations and institutional policies relating to the protection of human subjects in research conducted at or through JHU. This role provides advice to investigators, research staff, and other members of the broader JHU human research community, including researchers at non-Hopkins sites relying on the review of the JHU IRBs. - Interpret and apply all aspects of pertinent government regulations and institutional policies pertaining to human subjects research and related matters. - Review applications submitted to the IRBs to identify deficiencies under federal and state laws and regulations, and institutional policies that must be corrected prior to IRB review. - Determine that appropriate protocol- and application-specific documentation is submitted, e.g., requests for waiver of consent, waiver of HIPAA authorizations, formal communications from the FDA or commercial sponsors. - Assist in the review of IRB action outcomes, including the IRB’s minutes where required, and determine that regulatory, legal, and policy issues and their outcomes are documented appropriately. - Attend weekly IRB meetings to provide regulatory expertise, monitor proceedings, and assist staff with regulatory documentation issues. - Provide ongoing regulatory advice to JHU IRBs and JHU investigators and study team members. - Lead regulatory consults with faculty to assist with protocol planning and addressing complex regulatory issues that may arise as part of the IRB submission and review process. - Develop and lead educational offerings for IRB staff, IRB members and Chairs, and JHU research teams. - Prepare reports of serious non-compliance, continuing non-compliance, or unanticipated problems involving risks to participants or others. - Independently review select research applications, e.g. new applications, further study actions, relevant single IRB applications, as an IRB member and work with faculty/research staff to identify deficiencies to correct prior to IRB approval. - Other duties as assigned. Qualifications - Juris Doctor (JD) from an accredited law school. - Member of the Bar of the State of Maryland in good standing (or admitted to the bar of another state), or eligible to sit for the bar exam; continued employment is contingent upon passing the bar exam within one year of start date. - Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula. Preferred Qualifications - Three years of compliance or administrative experience related to human subjects research. Requirements - Classified Title: Human Research Compliance Associate - Role/Level/Range: ATP/04/PE - Starting Salary Range: $73,300 - $128,300 Annually ($85,000 Starting salary) - Employee group: Full Time - Schedule: Monday - Friday 8:30am - 5:00pm - FLSA Status: Exempt - Location: Remote - Department name: SOM Admin Clinical Invest Human Subjects - Personnel area: School of Medicine

Role Description We are seeking a Compliance & Verification Administrator (Quality Assurance) to support one of our U.S.-based healthcare clients who provides early intervention services. This is a highly task-oriented and repetitive role that requires strong attention to detail, consistency, and proactive follow-up. - Each therapist must comply with certain tasks to ensure that services being rendered are documented accurately and billed effectively. - The Compliance & Verification Administrator will be responsible for reviewing, verifying, and processing client and provider documentation to ensure compliance with regulatory and internal requirements. - This role involves repetitive tasks, so candidates must be comfortable with routine work while maintaining accuracy and focus. - The ideal candidate will be proactive, organized, and able to hold providers accountable for compliance requirements. PLEASE NOTE: - Working Hours: This role requires you to work EST hours Mon - Fri from 8am to 5pm EST (14h00 to 23h00 South African time - subject to change in accordance with daylight savings in the United States). - You will be required to work on both South African and US public holidays (compensation for SA public holidays in accordance with the BCEA). - Internet Requirements: A fixed fibre line with a minimum speed of 25 Mbps (upload & download) and the ability to support a wired Ethernet connection is mandatory. Applicants without a fixed fibre line cannot be considered. - Power Backup: A reliable power backup solution is required to manage load shedding and power outages. Applicants without a power backup cannot be considered. - Work Environment: This is a fully remote working role. Qualifications - Excellent written and verbal English communication skills. - High attention to detail — accuracy is critical. - Strong organizational and multitasking abilities. - Proactive and consistent in follow-up. Requirements - Basic computer literacy, including MS Office and Outlook. - Ability to navigate multiple systems and portals. - Experience with healthcare or early intervention documentation, compliance tracking, or working with therapy providers is a plus. - Previous experience in verification, compliance, or documentation review is a plus. Key Responsibilities - Verify and review therapists session notes for accuracy and completeness. - Analyze data to identify anomalies or patterns that may indicate fraudulent activity. - Coordinate with internal departments to ensure all documentation is complete and accurate. - Review enrolment requirements and supporting documents to confirm authenticity and validity. - Communicate with therapists and providers to hold them accountable for compliance. - Log into the HCSIS system and accept assigned cases promptly. - Review Individualized Family Service Plans (IFSPs) and Evaluation Reports (ERs) within required timelines. - Upload verified documents into the provider portal. - Manage and document PEIDs-related emails. - Prepare and send welcome letters to clients/families during onboarding. Company Description ISTA Personnel Solutions South Africa is a fast-growing global BPO. We are not a recruitment agency — we operate as a dedicated extension of our US-based clients’ teams, providing skilled remote professionals who support daily operations with precision, efficiency, and a personal touch.

• Take responsibility for one or more projects • Lead a project team and ensure that expectations are met • Introduce and implement best practices and methodologies to create value for the client • Conduct workshops, gather requirements, manage vendor selection and execute data migrations • Act as the liaison between the company and software vendors • Improve business processes • Promote a culture of knowledge sharing • Identify and propose opportunities to improve team performance

Title: Global Regulatory Compliance Director Work mode: Hybrid Onsite Location(s): Marlborough, MA, US, 01752 Additional Location(s): US-MN-Arden Hills Job Description: At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About the role: Boston Scientific is seeking a Global Regulatory Compliance Director, Internal Audit for its Global Quality Systems group. The purpose of this role is to provide strategic leadership, governance, and stewardship of the GRC internal audit team, the global internal audit process, and the Internal Audit Community of Practice. The Global Regulatory Compliance Director will work as part of a broad, global team within the Global Quality System and partner with site, divisional, regional, and corporate Quality leadership to identify compliance risks, strengthen internal controls, and drive sustained audit readiness across the BSC network. The Global Regulatory Compliance Director will set the vision for a risk-based internal audit program that supports adherence to the BSC Quality System and applicable global regulations. They will ensure the internal audit process is strategically governed, effectively maintained, and continuously improved in support of Corporate and Site quality objectives. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Your responsibilities will include: - Lead, coach, and develop a global team of quality system audit leaders and auditors responsible for executing the Corporate audit schedule and global risk-based audit strategy. - Define and deploy the multi-year internal audit strategy in partnership with Quality leaders across the BSC network, ensuring the audit program is data-driven, risk-based, and aligned with enterprise quality priorities. - Provide strategic oversight and escalation support for the identification, documentation, communication, and remediation of significant quality system nonconformances against external regulations and internal SOPs/WIs. - Serve as the global process steward and accountable leader for the Internal Audit process, including governance, process performance, health metrics, and strategic priorities. - Own the internal audit strategic process roadmap and lead the Internal Audit Community of Practice to drive alignment, standardization, and best-practice sharing across sites, divisions, and regions. - Sponsor auditor capability building, training strategy, technical tools, digital enablement, and continuous improvement efforts that strengthen a preventive quality culture. - Assess changes to standards, regulations, and regulatory expectations applicable to the assigned area, determine potential impact to BSC, and sponsor projects to ensure continued compliance. - Provide executive leadership for external audit readiness and execution, including front room and back room governance, SME preparation, storyboard strategy, and site-level support for Global procedures. - Deliver measurable process improvements through the VIP model and oversee year-over-year savings and productivity commitments against multimillion-dollar goals. - Sponsor and, when appropriate, act as CAPA owner for corrective actions and systemic improvements necessary to improve global processes and sustain compliance. - Champion departmental, cross-functional, and enterprise quality initiatives that advance compliance, audit readiness, and Quality System effectiveness. - Apply sound, systematic problem-solving and executive decision-making methodologies to identify, prioritize, communicate, and resolve complex quality and compliance issues. Required qualifications: - Minimum of Bachelor's degree in a relevant field - Minimum of 10 years of Medical Device Quality Systems experience, including extensive experience leading or overseeing internal and/or external audit programs - Strong understanding of regulations and standards applicable to the BSC Global Quality System (ISO 13485, 21 CFR 820, EU MDR, etc.). - Demonstrated inclusive leadership skills with experience leading, developing, and influencing global teams and senior stakeholders - Ability to travel up to 25% domestically and internationally Preferred qualifications: - Advanced degree - Experience working with or within an external notified body, competent authority, or regulatory agency - Pharmaceutical or combination-product experience - Digital product ownership, data analytics, audit technology, and/or IT project experience - Strong executive presence, analytical capability, and communication skills - High degree of integrity, professionalism, and the ability to establish credibility internally and externally, including with senior leaders and regulators - High sense of urgency, strategic judgment, and commitment to execution in a complex global environmen Requisition ID: 629998 Minimum Salary: $ 162400 Maximum Salary: $ 308600 Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.