EMEA Regulatory Consultant providing expertise on EU and UK regulatory frameworks impacting fintech and financial services. Bridging regulatory expectations with product development for compliance solutions.
About the role
- Quality and Regulatory Compliance Analyst at TRIMEDX focusing on compliance data for accreditation and audits. Collaborating with QA teams on data integrity and regulatory compliance tasks.
Responsibilities
- Conduct targeted analysis of repair and preventive maintenance data related to QRC internal audits and data audits criteria to ensure compliancy to federal state and local regulations and accreditation standards
- Compile data and perform analysis for equipment make/models/description and modalities, as well as equipment risk to ensure standardized MMD creation, maintenance and improvement
- Support Quality and Regulatory Specialists with reporting criteria and analysis of effectiveness verification post audit and CAPA completion
- Identification, monitoring and assistance with risk/opportunity assessment across the organization
- Provide oversight, monitoring and analysis with regulatory compliance requirements
- Assist with MMD matching of new and existing customer inventory in accordance with TRIMEDX MMD standardization processes and best practices
- Conduct analysis and comparison of alerts and recalls in determining impact to TRIMEDX organization and timely closure of loop
- Monitor, measure and produce QRC reporting necessary for Quality Management Review on a monthly/quarterly basis
- Support Quality and Regulatory Specialists with reporting criteria during site inspections and surveys
- Lead QMS internal audit activities (per ISO 13485, 27001 and/or applicable regulatory standards)
- Create, manage and monitor PM Transition Plan and Tools for new site implementations and existing sites with PM compliancy gaps
- Based on data analysis results and organizational feedback; partner with cross functional areas when the development of new processes, products, services, or relationships is required
- Develop best practices and business rules to ensure uniformity in work, deliverables and outcomes
- Assist with creation, analysis and maintaining standardized reporting of Pilgrim CAPA progress and effectiveness verification
- Creation, maintenance and improvement of data audit and remote internal audit tool for QRC team and external field facing documentation
- Participate in AEM (Alternative Equipment Maintenance) and PM Variance Committee by producing pertinent data pull and analysis related to PM Frequency Change and AEM Program requests and speak to outcome of analysis to committee members to drive decision making processes related to equipment risk and PM frequencies
- Monitor, measure and communicate compliancy gaps and risks in a timely manner to ensure mitigation of risks to patient safety and compliance
- Demonstrate competency as a QRC subject matter expert for RSQ and QMS software program analysis
- Assist with prompt response and actions related to QRC ServiceNow requests (PM Frequency Changes, PM Not Needed Requests, AEM Program Review, Bulk QRC requests)
Requirements
- Minimum of 3 years of experience in clinical engineering, quality, compliance, with demonstrated competency in data analysis, reporting, and application of problem solving
- Experience with complex reporting and analysis to ensure QRC data integrity and compliancy
- Strong demonstrated proficiency with Microsoft Office applications; advanced skills with Advanced Excel and Access required (Sequel, Qlik, Tableau experience a plus)
- Basic knowledge and application of ISO 13485, 9001 and/or 27001 standards and applicable regulations
- Knowledge of healthcare industry, regulatory compliance, clinical engineering, medical technology, and/or healthcare support services preferred
- Knowledge of ISO 9001, 13485 and/or 27001 preferred
- Strong analytical and interpretation skills to understand complex regulations and data analysis related to compliancy
- Strong written and verbal communication skills supporting interactions with personnel at all levels within the organization
- Creative thinker with ability to meet stringent and changing deadlines with accuracy
- Change management and customer focused.
Benefits
- Drug-Free Workplace
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