Role Description The Senior Regulatory Expert - Medical Devices will oversee and define roadmap for the global regulatory submissions for US Class I and II and EU Class A, B and C in vitro diagnostic medical devices to global regulatory agencies and/or to commercial partners. - Oversee and define roadmap for global regulatory submissions for US Class I and II and EU Class A, B and C in vitro diagnostic medical devices. - Develop and implement strategic frameworks for compliance requirements in various regions including USA, EU, Canada, UK, Switzerland, and others. - Provide regulatory insights and action plans to cross-functional teams to ensure compliance with regulations such as IVDR, FDA 21 CFR 820, and ISO 13485:2016. - Independently author, compile, and maintain technical files and regulatory documentation for timely registrations and renewals. - Review and approve quality management system documentation related to post market surveillance and risk management. - Respond to regulatory inquiries and participate in inspections by authorities and notified bodies. - Implement strategic frameworks for assessing regulatory implications of engineering changes. - Monitor and analyze global regulatory developments and lead regulatory surveillance activities. - Manage regulatory review process for labeling materials ensuring compliance with global regulations. - Provide regulatory assessment for new product development initiatives. - Manage recall or notification actions and ensure effective execution of regulatory vigilance reporting. - Mentor junior team members to support their onboarding and development. Qualifications - Bachelor of Science degree in pharmacy, biology, chemistry, pharmacology, chemical engineering, or a closely related field. - At least seven (7) years of progressively more responsible work experience in global regulatory strategies for in vitro diagnostic medical devices. Requirements - Demonstrated knowledge of medical device or in-vitro diagnostics regulatory compliance. - Ability to author complex regulatory technical documentation for submission to competent authorities. - Experience utilizing software tools for Robotic Process Automation (RPA) solutions. - Ability to conduct regulatory impact assessments and identify regulatory risks early in the process. Benefits - Generous benefits packages.

This role involves providing support to the patient care team by offering virtual continuous observation of multiple patients to ensure safety and prevention of injury using technology. Communicates with members of the healthcare team Navigates clinical systems to retrieve necessary information to provide care Collaborates with other healthcare professionals to ensure effective and efficient patient care delivery Aims for the achievement of desired patient outcomes

The UM Clinical Specialist-Behavioral Health performs professional and administrative work, primarily utilization reviews, utilization management and active care management to ensure economical and effective consumer service delivery by PHIP enrolled network providers; The position is responsible for providing medical necessity reviews of individualized service plans and requests for authorization of services to ensure consumers receive services in the least restrictive, most integrated setting appropriate to the individual’s needs; The primary role is to review for services under the Medicaid B waiver and state funded benefits; complete related work as required. This position is fulltime remote. Selected candidate must reside in North Carolina. Some travel for onsite meetings to the Home office at Morrisville may be required. Responsibilities & Duties Utilization Reviews and Management Independently conducts medical necessity reviews of service requests submitted by service providers against developed clinical guidelines within contractually mandated turn-around times Conducts utilization reviews to monitor adherence to clinical practice guidelines and best practice standards and to determine if services were delivered as requested Engage in care management activities to ensures individuals receive appropriate referral for treatment including; consumer and provider follow-up calls, case staffing with psychologists and medical staff Monitors consumer person centered plans to ensure that effective treatment interventions are utilized, provide consultation to treating providers when person centered plan requires adjustments to better meet consumer needs Monitors and reports consumer and provider specific over/under utilization Conducts utilization reviews to monitor for over/under utilization Program Operation and Management Identify high risk consumers and those with special health care needs for referral to Care Coordination and case escalation Provides linkage, authorizations and level of care determinations, assisting providers and Care Coordinators with creative problem solving to recommend alternative approaches to care Ensures compliance with care management and quality improvement policies and procedures, utilization review laws and regulations, state standards Promote access to appropriate, effective and quality treatment Monitors for undesirable performance or deviations of practice standards through care management activities that may have a negative impact on consumers. Responds through additional follow-up with consumer and providers, provider technical assistance and/or referral to other departments within the MCO Administrative Functions Notifies members of adverse benefit determinations while preserving members’ Due Process rights Engages in routine follow-up to ensure consumers are engaged in treatment and services are being delivered as requested Documents utilization review decisions in computerized authorization management system Maintain professional licensure Engages in training as needed to stay informed of changes in best practice for supporting the needs of individuals with MH/SUD/IDD Minimum Requirements Education & Experience : Master’s degree in a Human Services field (such as Psychology, Social Work or Counseling) and at least five years of post-degree progressive experience providing similar services to the population served (MH/SUD). Requires current and active license issued by a North Carolina Professional Board, as a LCSW, LCAS, LP, LPA, LMFT, LCMHC or RN. OR A master's degree in psychiatric nursing which provides the knowledge, skills, and abilities needed to perform this work; or graduation from a State accredited school of nursing and two years of experience in psychiatric nursing which provides the knowledge, skills, and abilities needed to perform the work; or an equivalent combination of education and experience. Preferred : Experience in the public behavioral healthcare field is highly desired due to the complexity of the work. Experience in a UM environment in Behavioral Healthcare would be valuable for this employee. Knowledge, Skills, & Abilities Considerable knowledge of case management principles, practices and applications Considerable knowledge of agency and community programs and services which affect clients and applicants Knowledge of state and federal client rights protection statues and regulations applicable laws and regulations including but not limited to URAC, applicable Code of Federal Regulations and NC Administrative Code Effective written and oral communication skills and interpersonal and presentation skills Ability to identify rights protection complaint issues; ability to set, monitor and evaluate standards for quality and to assess plans to measure how they meet the needs of individual clients Considerable knowledge in DMS 5 diagnostic criteria Ability to manage time, prioritize work and use problem-solving approaches Ability to coordinate effectively with staff from a various agencies as well as inter-departmental Ability to read, analyze, and interpret regulations, policies and procedures Coordinate work with a variety of individuals and agencies Ability to operate computer equipment and generate reports and records; ability to express ideas clearly and concisely orally and in written documents Proficiency in Microsoft Office products (such as Word, Excel, Outlook, etc.) is required Employment for this position is contingent upon a satisfactory background check, which will be performed after acceptance of an offer of employment and prior to the employee's start date. Salary Range $68,227 - $86,990/Annually Exact compensation will be determined based on the candidate's education, experience, external market data and consideration of internal equity. An excellent fringe benefit package accompanies the salary, which includes: Medical, Dental, Vision, Life, Long and Short Term Disability Generous retirement savings plan Flexible work schedules including hybrid/remote options Paid time off including vacation, sick leave, holiday, management leave Dress flexibility

• Clinical leader of one or more endocrinology programs, being integral to developing the clinical strategy and plans • Member of global project team(s) and development sub team(s) • Focus on immediate and short-term (<2 years) strategic planning horizon • Contribute as the Clinical Research expert to the conception and regular modifications of the Target Product Profile (TPP) • Lead the development of the Clinical Development Plan (CDP) for each indication being pursued • Conceive and write the Clinical Study Outline for each study in the CDP • Lead the discussions and oversee the writing of the study synopsis, study protocol and its amendments • Review or oversee the review on a regular basis the data input in the EDC for events of interest or needing further investigation and all reports generated from ongoing clinical studies • Provide senior‑level medical monitoring and safety oversight in cooperation with pharmacovigilance • Collaborate with other departments (Biometrics, Clinical Operations, Medical Affairs, a.o.) in all topics related to the conduct and analysis of clinical study results • Guide interpretation of clinical data • Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings • Support advisory boards, key opinion leader engagement, and external scientific collaborations • Contribute to the development of relevant sections of regulatory documents such as amendments to protocols, briefing books, safety updates, responses to Health Authorities questions