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Volt is immediately hiring a Remote-German Speaking-Medical Device Regulatory Affairs Specialist II with a well-known industry leader. As a Regulatory Affairs Specialist II you will: Have a significant impact on country registrations and labeling changes that are needed for medical devices, and some drug products.
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Cross-functional Collaboration with various departments, including logistics, finance, Tax, legal, finance, Govt Affairs, ITQ/FSQ, Global Security, External Supply Chain, and Sourcing, to align global trade practices with overall business objectives.
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Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment.
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Regulatory Compliance: Stay updated on relevant laws, regulations, and industry best practices related to third-party risk management. Due Diligence: Perform due diligence on third-party suppliers to ensure they meet the organization's standards and regulatory requirements.
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
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Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR). Participation in FDA regulatory meetings, especially panel preparation and presentation Experience writing or updating clinical reports/documents.
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Members of our department collaborate with federal and state partners, such as the MN Department of Natural Resources, the USDA Forest Service Northern Research Station, the Bureau of Indian Affairs, the National Park Service, and the US Geological Survey, many with offices on our campus.
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Possess CISSP certification (or similar) and be knowledge of national and international regulatory compliances and frameworks such as ISO, SOX, BASEL II, EU DPD, HIPAA, and PCI DSS. Develop a risk-based cyber security program which meets regulatory requirements and aligns with industry leading information security practices.
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RELATIONSHIPS Reports to: Associate Director of Enrollment Internal relationships with: Admissions team, Financial Aid, Registrar, Student Affairs, Academic Dean and Faculty, Seminary Relations, Contextual Learning, Library, Writing Center, Dean of the Chapel, Stewardship, Office of Technology.
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Must have a strong understanding of a firm back-office and financial reporting functions such as reserve formula, FOCUS report, possession and control, stock record, general ledger, trade blotters, margin requirements, time critical regulatory functions (e.g., buy-ins, sell outs), record retention, access control procedures, and cybersecurity.
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Develop and maintain best practices, standards, and guidelines for data management, data governance, and data security in alignment with regulatory requirements and industry standards. Experience in developing partner led sales in collaboration with data platform and tool vendorsIn-depth knowledge of big data technologies such as Hadoop, Spark, Kafka, and cloud platforms such as AWS, Azure, GCP, Snowflake, Databricks, etc.
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Help drive system and product requirements to meet the regulatory and compliance requirements (like GDPR, ISO, ISA/IEC, SOC2, FedRAMP) Assist with training and mentoring of security champions. Help drive system and product requirements to meet the regulatory and compliance requirements (like GDPR, ISO, ISA/IEC, SOC2, FedRAMP) Assist with training and mentoring of security champions.
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The candidate will play a crucial role in advising clients on a wide range of environmental matters, including mergers and acquisitions, real estate transactions, permitting, regulatory compliance, and risk mitigation.
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The district geography includes 8-10 territories that will cover ND, SD, NE, MN, WI, Upper Peninsula of Michigan, and western Iowa. The DSM will be responsible for driving business results through effective cross-functional leadership and collaboration with Sales Leadership, Medical Affairs, and other key internal and external stakeholders.
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Tasks may include conducting and/or overseeing wetland delineations, inventories, and functional assessments; performing botanical and wildlife surveys; developing permit applications; planning wetland mitigation projects (including construction oversight); preparing environmental impact assessments; and negotiating with regulatory agencies.
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regulatory affairs jobs Title: regulatory affairs manager in Falcon Heights, MN
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