Working Location: NATIONWIDE Workplace Flexibility: Remote For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​ ​ Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. ​ Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus: https://www.olympusamerica.com/careers. Job Description Responsible for the review of medical device global complaints and coordinate the resolution of complex complaints (For example: death, serious injury, legal papers, and literature reviews). The Analyst Ill requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, 21CFR820, 21CFR806 and 21CRF803 and will also have an understanding of global adverse event reporting criteria (For example: Europe, China, Australia, Latin America, Japan, and others). The Analyst Ill is responsible for determining medical device reportability for Olympus products or products for which Olympus has contractual obligations, and performs clinical assessments as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas of responsibility is required. Supports and may represent the Medical Device Reporting Process in internal and external audits. Prepares responses to standard requests from a regulator, as needed. Supports due diligence process in obtaining information cross-functional and external to Olympus. Functions as team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance. Performs routine assignments independently; supports and mentors lower-level staff; initiates new or special assignments with occasional direction from Manager. Must have ability to work in a team environment and be self-motivated and organized. Job Duties - A seasoned, experienced professional with a full understanding of complaint handling - Reviews complex complaints such as death, serious injury, legal papers, and literature reviews for medical devices independently. Ensures complaint files have an appropriate resolution and/or justification. - Responsible for assessing complaints, completing decision trees, and documenting reportability in the system in a consistent and timely manner in accordance with 21 CFR Part 803 Medical Device Reporting . - Prepares and reviews MD Rs/Importer/Supplemental reports for the FDA for complex complaints. - Responsible for the coordination of complaint related tasks with other cross-functional team members and the local RA/QA representatives for countries outside of the US and ensuring reportability decisions are made and reports are filed in a timely manner. - This position may interact with internal and external customers, sales organization, local RA/QA representatives, healthcare providers, nurses, patients as well as external regulatory bodies, such as US FDA and notified body, concerning products issues, product information, patient requests and complaints and contributes to the preparation of responses to standard requests and extended requests from Regulatory Bodies. - Acts as a resource for department staff members on complex complaints. - Completes Clinical Assessments for complex cases and upon request, when appropriate. - Monitors progress of all ongoing complaint activities and MDRs to ensure the timely submissions. - Documents and maintains records of adverse events reports in accordance with internal procedures and applicable regulatory requirements. Completes all required customer complaint/adverse event related documentation in an accurate, professional and timely manner. - May also be asked to represent and support the Medical Device Reporting Process in internal and external audits. - Provides training during orientation and on-boarding of new staff. Mentors staff members regarding complaint processing. - May provide assistance to junior level staff with general tasks that require a better understanding. - Processes reportability decisions and is able to complete MDR submissions. - Assist in the preparation of regulatory body additional information requests. Functions as a team member/ leader in collaboration. - Lead/Manage special assignments/ projects with Global MDR Submission or across functional areas. - Must have ability to work in a team environment and be self-motivated and organized. - Other duties as assigned. Job Qualifications Required: - Bachelor of Science degree, or Associate of Science and Licensure in Nursing from an accredited college or university Bachelor of Science degree in any of the relevant scientific discipline. - A minimum of 3 years of related experience on the medical device industry with attention to complaint handling and adverse event reporting and/or post-market surveillance organization strongly preferred; OR A minimum of 3 years of experience on the healthcare/clinical setting or other points of care; OR An equivalent combination of 3-5 years medical device and clinical experience. - The ability to read, write and communicate effectively in English is required; includes clear, understandable speech and demonstrated comprehension skills. - Must possess excellent verbal and written communication skills. - Must be able to demonstrate a working proficiency in operating a personal computer and to perform basic word processing/spreadsheet tasks using Microsoft Excel and Word applications. - Ability to effectively prioritize and manage workload. - Organization, prioritization, and familiarity with working in a regulated industry setting. - Able to consistently meet deadlines despite high volume. - Competency in computer software/hardware will also be useful in resolving or elevating IT concerns and issues. - Able to work under pressure. - Strong feeling for Accountability. - Strong critical thinking, communication, problem-solving skills, and detail oriented. - Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors. - Knowledge/ ability to utilize various software/ database sources. - Must be able to maintain good attendance regular scheduled hours. - Must be able to follow standard practices and procedures. - Attention to detail and accuracy required. - Strong analytical and organizational skills required. - Must be able to prioritize workload in order to meet regulatory/ procedural deadlines. - Basic knowledge of medical terminology and human anatomy. - Demonstrated working knowledge of Medical Device Quality Systems regulations including ISO 13485, 21 CFR820, and 21 CFR803. Experience with utilization of TrackWise or ETQ preferred. - Applies professional concepts and company policies and procedures, analyzes data or situations, and exercises judgment to recommend solutions to solve problems. - Follows standard practices and procedures in analyzing situations or data from which answers can be obtained. Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on: - Competitive salaries, annual bonus and 401(k)* with company match - Comprehensive medical, dental, vision coverage effective on start date - 24/7 Employee Assistance Program - Free live and on-demand Wellbeing Programs - Generous Paid Vacation and Sick Time - Paid Parental Leave and Adoption Assistance* - 12 Paid Holidays - On-Site Child Daycare, Café, Fitness Center** Connected Culture you can embrace: - Work-life integrated culture that supports an employee centric mindset - Offers onsite, hybrid and field work environments - Paid volunteering and charitable donation/match programs - Employee Resource Groups - Dedicated Training Resources and Learning & Development Programs - Paid Educational Assistance *US Only **Center Valley, PA and Westborough, MA Are you ready to be a part of our team? Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks. The anticipated base pay range for this full-time position is $85,266.00 - $115,109.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual. Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications. At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com. You Belong at Olympus We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787). Let’s realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)

• Manage billing for enterprise-level clients • Partner closely with cross-functional teams to validate billing inputs • Review and maintain billing schedules, perform reconciliations • Identify inefficiencies or recurring billing issues and drive solutions • Support month-end close processes by ensuring timely revenue recognition

What this Job Entails: The primary focus of the PCM Analyst will be on providing modeling, data analytics and pricing support to enable agile and effective decision making at some of our largest clients as well as around key corporate initiatives. The individual in this role must have the ability to work across functions, departments, excels at problem solving through critical analysis, and is challenged by process review and continuous improvement. This role will be a key contributor to our pricing and margin analysis process, be a key facilitator to the annual planning and monthly forecasting process, and drive recommendations for creative solutions to analysis and reporting. Scope: - Resolves a wide range of issues in creative ways - Works on problems of moderate scope - Receives general instructions on routine work and detailed instructions on new projects Your Roles and Responsibilities: - Collaborate with the Sourcing team to obtain product cost data. - Collaborate with PLM (Product Lifecycle Management) and Engineering teams to monitor and verify BoM changes. - Utilize internal cost system to generate BoM (Bill of Materials) cost rollup and comparison report. - Setup and maintain correct personnel, assembly and commodity settings in the cost system. - Assist in generating bi-weekly, monthly and ad-hoc product cost reports. - Identify and track appropriate performance measures, leading key performance indicators and associated drivers. - Be proactive in reviewing information, identifying inconsistencies, trends and issues for management. - Assist in maintaining consistent processes and standard formats, as well as design reporting summaries and scorecards. - Identify and understand opportunities and risk potential in the forecasts and help analyze their impact. - Support efforts in preparing communication to management and executive teams on areas of concern and actions required to meet financial commitments. - Support report automation efforts for the group; assist in the assessment and implementation of decision support tools. - Other duties as required. This list is not meant to be a comprehensive inventory of all responsibilities assigned to this position Required Qualifications/Skills: - Skilled in spreadsheets and data analysis - GSuite knowledge - SQL/Python Experience - Ability to work PST hours - Strong written, interpersonal and verbal communication skills - Bachelor’s degree (B.S/B.A) from four-college or university and 4 to 6 years’ related experience and/or training; or equivalent combination of education and experience Salary Range $31.79 - $50.19 USD (Hourly) - Please note that the salary information provided herein is base pay only (gross); it does not include other forms of compensation which may or may not apply to this specific position, namely, performance-based bonuses, benefits-related payments, or other general incentives - none of which are guaranteed, may be subject to specific eligibility requirements, and are wholly within the discretion of Astreya to remit. - Further, the salary information noted above is a range that consists of a minimum and maximum rate of pay for this specific position. Where an applicant or employee is placed on this range will depend and be contingent on objective, documented work-related considerations like education, experience, certifications, licenses, preferred qualifications, among other factors. Astreya offers comprehensive benefits to all Regular, Full-Time Employees, including: - Medical provided through UHC (PPO, HSA, Surest options) / Medical provided through Kaiser (HMO option only) for California employees only - Dental provided through UHC - Nationwide Vision provided by UHC - Flexible Spending Account for Health & Dependent Care - Pre-Tax Account for Commuter Benefit/Parking & Transit (location-specific) - Continuing Education and Professional Development via various integrated platforms, e.g. Udemy and Coursera - Corporate Wellness Program provided by Goomi Group - Employee Assistance Program - Wellness Days 401k Plan - Basic and Supplemental Life Insurance - Short Term & Long Term Disability - Critical Illness, Critical Hospital, and Voluntary Accident Insurance - Tuition Reimbursement (available 6 months after start date, capped) - Paid Time Off (accrued and prorated, maximum of 120 hours annually) - Paid Holidays - Any other statutory leaves, paid time, or other ancillary benefits required under state and federal law

Department Name: IT Clinical Care-Corp Work Shift: Varied Job Category: Information Technology Estimated Pay Range: $39.00 - $65.00 / hour Banner Health is committed to pay equity and transparency. The posted compensation range is a reasonable estimate that extends from the lowest to the highest pay Banner Health in good faith believes it might pay for this particular job, based on the circumstances at the time of posting. This range is based on possible base salaries and does not include the value of our total rewards package. Actual pay determined at offer will be based on years of relevant work experience, education, certifications, skills, and geographic location, along with a review of current employees in similar roles to ensure pay equity is achieved and maintained. Banner Health was named to Fortune’s Most Innovative Companies in America 2025 list for the third consecutive year and named to Newsweek's list of Most Trustworthy Companies in America for the second year in a row. We’re proud to be recognized for our commitment to the latest health care advancements and excellent patient care. Banner Health is seeking an IT Clinical Solutions Analyst II. This position is responsible for planning, organizing, and day-to-day management of information technology projects and database management related to Laboratory applications. The incumbent participates in the development and implementation of information technology strategies to achieve desired outcomes. Includes analysis of clinical, business, and user needs maintaining compliance with regulatory and documentation requirements. Acts independently or as part of a team to provide knowledge, guidance, and research expertise to define, design, and modify specifications and processes. This can be a remote position if you live in the following states ONLY: Al, AK, AR, FL, GA, ID, IN, IA, KS, KY, LA, MD,MI, MN, MS, MO, NH, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI AZ CA CO NE NV WY. No other states will be consider. Your pay and benefits (Total Rewards) are important components of your Journey at Banner Health. Banner Health offers a variety of benefit plans to help you and your family. We provide health and financial security options, so you can focus on being the best at what you do and enjoying your life Within Banner Health Corporate, you will have the opportunity to apply your unique experience and expertise in support of a nationally-recognized healthcare leader. We offer stimulating and rewarding careers in a wide array of disciplines. Whether your background is in Human Resources, Finance, Information Technology, Legal, Managed Care Programs or Public Relations, you'll find many options for contributing to our award-winning patient care. POSITION SUMMARY This position is a high level strategic contributor with expertise in selected business or healthcare processes and is responsible for formulating system scope and objectives relative to the business requirements utilizing previous clinical expertise. Acts independently or as leader of a team to provide knowledge, guidance, research and fact-finding expertise to define, design and modify specifications and processes of complex information systems. Responsible for establishing system documentation standards and quality assurance methodologies for systems and applications. CORE FUNCTIONS 1. Business Outcomes: Identifies, investigates, tracks, and resolves multi-level project, system or application errors ensuring the resolution is timely with a high degree of accuracy and quality. Determines which option is appropriate based on the unique situation. Ensures timely updates and communication to the customer. Designs end user training and curriculum for applications and systems. Facilitates the initial rollout and ongoing support of the user community. Assesses and develops strategies for achieving the needs of internal and/or external customers. Defines expectations. Strives to meet customer’s identified outcome. 2. Technology Standards: Designs and administers complex standards and policies regarding application and end user customer documentation. Ensures that department and company standards are implemented and consistently adhered to. Responsible to create technical documents to include- process maps, Business Requirement Documents, system diagrams, application maps, test plans, work instructions, etc. Stores documents in central location for broader IT access. Provides high level expertise to the development of fully integrated testing scenarios. Provides information to be taken into account as part of the comprehensive functional and integration testing plans. Coordinates change management documentation and ensures that approvals are managed according to departmental procedures and ITIL standards. 3. Innovation and Futures: Offers constructive advice on processes, functions, and re-design opportunities resulting from the implementation of technology. Can present broad, complex information and concepts in an influential or persuasive way that results in action. 4. Advisor and Partner: Provides leadership for company staff, information technology staff and various committees guiding the design, implementation and maintenance of complex application and system specifications and processes. Participates and may lead taskforces to plan, implement, and coordinate facility activities to maximize information technology service quality, effectiveness and efficiency. Maintains current professional and technical knowledge related to the healthcare industry by attending educational workshops/conferences, establishing personal networks, and/or maintaining relevant certification or licensure as business needs require. 5. Communication: Identifies and improves communication to bring team conflict into the open and facilitate resolution. Values differences and creates a diverse team. Identifies the "right people", despite functional specialty, for inclusion in the team by matching individual competencies to the team's goals. Presents information or ideas to the interests, level and needs of the audience. Actively engages participants and encourages input. Promotes and facilitates free and open communication. Adapts choice of language and presentation of ideas to fit various needs and perspectives of audiences. 6. Measurements: Ensures Key Performance Indicators are supported and tracked in all levels of work effort. Clearly defines success and implements the measurements to understand when success is achieved. 7. Strategic/Leadership: Understands and actively engages in the identification of business and technical solutions for multiple or cross-functional business areas. Provides expertise and guidance to the user community and mentors junior members of the department. Identifies and acts upon opportunities for continuous improvement. Encourages prudent risk-taking, exploration of alternative approaches, and organizational learning. Demonstrates personal commitment to change through actions and words. Mobilizes others to support change through times of stress and uncertainty. Takes risks and challenges the status quo with the intent to strengthen team and organizational performance. Shares knowledge, skill, or expertise with others. Coaches others. Encourages and reinforces personal and professional development. 8. Customer Service: Consistently displays awareness and sensitivity to the needs of internal and/or external customers. Proactively ensures these needs are met or exceeded; place the needs of the customer and team at the center of decision making. Quickly assesses the scope of an issue, providing options that lead to its closure. Determines which option is appropriate option based on the unique situation. Keeps customer informed of progress toward resolution. Performs all functions according to established policies, procedures, regulatory and accreditation requirements, ITIL and Service Management standards as well as applicable professional standards. 9. This position has high level responsibility for selected information applications or systems. Work is performed in a fast paced multi-tasked environment where there may be conflicting priorities or tight deadlines. The incumbent has decision-making authority for projects and applications and works at peer level across diverse areas and multiple states. The incumbent participates in meetings, presentations, visioning sessions, strategic and planning sessions, implementation activities, and supports functions company-wide. MINIMUM QUALIFICATIONS Requires a Bachelor’s degree or equivalent work experience and a current valid clinical license, certification, or credential in state of practice. Must also have in-depth knowledge of concepts within job function as would normally be obtained in four to seven years work experience in a healthcare environment. Must demonstrate general knowledge of information technology and healthcare. Needs experience in medium scale project planning and reporting, either individual or team. Requires communication and presentation skills to engage technical and non-technical audiences. Requires ability to communicate and interact across facilities and at various levels. Incumbent will have skills to mentor less experienced team members. As is typical in this industry, variable shifts and hours and carrying/responding to a pager may be required. PREFERRED QUALIFICATIONS Additional related education and/or experience preferred. EEO Statement: EEO/Disabled/Veterans Our organization supports a drug-free work environment. Privacy Policy: Privacy Policy