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Experts in digital solutions and regulatory and quality consulting services for the Life Sciences sector
Risk Manager – Medical Devices
Location
Portugal
Posted
91 days ago
Salary
0
Seniority
Senior
Job Description
Risk Manager – Medical Devices
Ambit Iberia
• Support the Risk and DQA team in their activities • Consulting team doing consulting projects • Work Closely with the software engineering team to create an excellent cross-functional relationship with the different teams involved • Cross-functionally manage the quality assurance of digital projects ensuring that deadlines, project plans and quality objectives are met • Promote organizational compliance with the quality system, on QMS Software and SDLC framework • Provide quality oversight during risk, Part 11, Annex 11 and regulatory
Job Requirements
- Strong experience (5+ years) in Quality, including QMS, Design Control, Risk Management, in the area of development, production, planning / quality assurance for Software / In Vitro Diagnostics or Medical Devices
- Experience in setting up and maintaining Quality Management System (QMS) related to Software products, under ISO 13485 and ISO 14971
- Risk management according to ISO 14971
- Advice, guidance and preparation of regulatory documentation prior to commercialization in EU
- Knowledge of MDR (EU) 2017/745 and/or (EU) IVDR 2017/746 regulations
- Fluent in English
- Spanish is highly valued
Benefits
- 100% remote position
- Flexible work schedule
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This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Office of Risk Management, within the Division of Business Services, has responsibility for assisting campus in preserving the human and physical assets of the university. This involves identifying, evaluating and controlling loss exposures to minimize the adverse effects of unpredictable events impacting the University. - Assist departments in their recovery efforts - Provide a variety of risk management services to campus, including: - Driver authorization program oversight - Certificate of insurance program administration - Automobile, liability, property and other claims handling services - Coordinate Worker’s Compensation claims in partnership with Divisional Human Resources Representatives - Assist employees who have sustained work-related injury or illness Qualifications - Experience or interest in risk management and/or occupational injury prevention - Risk Management, Business, Information Systems majors preferred - Ability to utilize database applications with attention to detail and accuracy - Strong interpersonal and communication skills, including the ability to develop and maintain effective working relationships with campus and Universities of Wisconsin System personnel - Ability to problem solve and/or refer inquiries to the proper individual - Ability to work independently and effectively under general supervision - Proficiency in MS Word and Excel and Adobe Acrobat - A passing score on a criminal background check (CBC) must be attained prior to hire Requirements - Excellent oral and written communication skills - Strong organizational skills, attention to detail and accuracy - Ability to work during Winter Break - Ability to utilize database applications Benefits - Fully remote position with very limited occasional onsite work for meetings or special project needs - Flexible scheduling with summer hours up to 30 hours per week and minimum 10 hours per week during semesters - Salary range: Minimum $14.00 - Maximum $20.00 Institutional Statements UW-Madison is an Equal Employment, Equal Access Employer committed to increasing the diversity of our workforce. Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background-people who as students, faculty, and staff serve Wisconsin and the world. For more information on diversity and inclusion on campus, please visit: diversity.wisc.edu If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: Disability Accommodation Information for Applicants
UM Coordinator II - Maternity Focus
BlueCross BlueShield of South CarolinaSouth Carolina’s largest and oldest health insurance company
Summary Performs medical/pharmacy reviews using established criteria sets and/or performs utilization management of services within the LPN/LBSW scope of practice to include but not limited to professional, durable medical equipment, home health services, and/or pharmacy requests covered under the medical plan. Documents decisions using indicated protocol sets or clinical guidelines. Provides support and review of medical claims and utilization practices. Assists with discharge planning as appropriate. Serves as a resource, mentor, and preceptor as needed. Description Why should you join the BlueCross BlueShield of South Carolina family of companies? Other companies come and go, but we've been part of the national landscape for more than seven decades, with our roots firmly embedded in the South Carolina community. We are the largest insurance company in South Carolina … and much more. We are one of the nation's leading administrators of government contracts. 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Policy Governance Professional
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Become a part of our caring community and help us put health first The Policy Governance Professional policy Governance is the combination of Compliance processes established and executed that are reflected in the organization's structure and how it is managed and led toward achieving goals. The Policy Governance Professional 2 work assignments are varied and frequently require interpretation and independent determination of the appropriate courses of action. The Policy Governance Professional supports the ongoing development, review, and management of Utilization Management (UM) policies and procedures. This role works closely with UM governance and relevant committees, ensuring documentation and reporting align with regulatory standards and organizational objectives. The position also assists with monitoring and reporting quality metrics, and is responsible for preparing clear, accurate written materials to support compliance and continuous improvement initiatives. 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SSN Alert Humana values personal identity protection. Please be aware that applicants may be asked to provide their Social Security Number, if it is not already on file. When required, an email will be sent from Humana@myworkday.com with instructions on how to add the information into your official application on Humana’s secure website. Travel: While this is a remote position, occasional travel to Humana's offices for training or meetings may be required. Scheduled Weekly Hours 40 Pay Range The compensation range below reflects a good faith estimate of starting base pay for full time (40 hours per week) employment at the time of posting. The pay range may be higher or lower based on geographic location and individual pay will vary based on demonstrated job related skills, knowledge, experience, education, certifications, etc. $65,000 - $88,600 per year This job is eligible for a bonus incentive plan. This incentive opportunity is based upon company and/or individual performance. 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Through our Humana insurance services and CenterWell healthcare services, we make it easier for the millions of people we serve to achieve their best health – delivering the care and service they need, when they need it. These efforts are leading to a better quality of life for people with Medicare, Medicaid, families, individuals, military service personnel, and communities at large. Equal Opportunity Employer It is the policy of Humana not to discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or protected veteran status. It is also the policy of Humana to take affirmative action, in compliance with Section 503 of the Rehabilitation Act and VEVRAA, to employ and to advance in employment individuals with disability or protected veteran status, and to base all employment decisions only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, upgrading, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation and selection for training, including apprenticeship, at all levels of employment.
External candidates: In order for your application to be correctly processed please sign-in before you apply Internal candidates: Please go to Workday and click "Find Jobs" link under Career Thank you for considering opportunities with us! Job Title Information Architecture Governance Advisor - Remote Requisition Number R7581 Information Architecture Governance Advisor - Remote (Open) Location Arizona - Home Teleworkers Additional Locations Alabama - Home Teleworkers, Alabama - Home Teleworkers, Arkansas - Home Teleworkers, California - Home Teleworkers, Colorado - Home Teleworkers, Connecticut - Home Teleworkers, Delaware - Home Teleworker, District of Columbia - Home Teleworkers, Florida - Home Teleworkers, Georgia - Home Teleworkers, Idaho - Home Teleworkers, Illinois - Home Teleworkers, Indiana - Home Teleworkers, Iowa - Home Teleworkers, Kansas - Home Teleworker, Kentucky - Home Teleworkers, Louisiana - Home Teleworkers, Maine Home Teleworkers, Maryland - Home Teleworkers, Massachusetts - Home Teleworkers, Michigan - Home Teleworkers, Minnesota - Home Teleworkers, Mississippi - Home Teleworker, Missouri - Home Teleworker, Montana - Home Teleworkers {+ 21 more} Job Information CSAA Insurance Group (CSAA IG), a AAA insurer, is one of the leading personal lines property and casualty insurance groups in the United States. Here, every employee shapes our mission. We build innovative, human-centered solutions that help AAA members prevent, prepare for, and recover from life's uncertainties. You will join a collaborative, inclusive culture where your strengths have room to grow and your ideas can drive real impact. Step into a role where you can contribute to our shared success through meaningful work. We are actively hiring for an Information Architecture Governance Advisor - Remote! Your Role: The Information Architecture Governance Advisor owns the design and implementation of an enterprise information model. Establishes and carries out enterprise data and information architecture policies, standards, and processes according to guidelines. Is responsible for structuring, organizing, and communicating information in a way that makes it easy for business users to find, navigate, and understand. Champions and facilitates the review of data-related changes across the organization. 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Our flexible workplace empowers you to balance remote work with intentional in‑person moments that deepen connection and collaboration. Inclusion and Belonging: An inclusive and welcoming workplace is the cornerstone of our success. By fostering an environment where people feel valued and heard, we deepen our ability to understand and meet the unique needs of our members. This strengthens innovation and enhances our products and services, giving us a competitive edge in the market. Sustainability: As climate change leads to more frequent and severe weather events, we are taking bold action to build more resilient communities and reduce our environmental impact. Submit your application to be considered. We communicate via email, so check your inbox and/or your spam folder to ensure you don’t miss important updates from us. CSAA is committed to providing reasonable accommodations to qualified applicants and employees with disabilities or other limitations. 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