Spectrum Vascular

Compliance

• Assist in the preparation, formatting, and compilation of regulatory submissions (e.g., FDA 510(k), EU MDR Technical Documentation)
• Support the maintenance of regulatory files, declarations of conformity, and device listings/registrations
• Support responses to regulatory agency requests for additional information
• Support U.S. and EU market approval processes and ensure compliance with regulatory standards
• Support post-market submissions (progress reports, annual reports, etc.)
• Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers
• Collaborate with Quality Assurance to ensure continued compliance with applicable regulatory standards
• Participate in internal audits, management reviews, and external audit preparations as needed

Regulatory Affairs Specialist

Financial Planning and Analysis

• Manage and lead the Finance team in financial modeling, forecasting, and reporting.
• Develop and implement budgeting and forecasting processes across the enterprise.
• Support the implementation of budgeting, forecasting and financial reporting tools.
• Provide training and guidance across the enterprise for budgeting tools and models.
• Drive continuous improvement, standardization, and automation to the budgeting and forecasting process.
• Develop, track and report on key performance indicators (KPI's).
• Develop financial models, prepare projections, and perform research and analysis for company leadership.
• Support cash flow forecasting and modeling.
• Conduct analyses and reporting for corporate functions including monthly financial analysis, reforecasting, variance analysis, pipeline analysis, and graphical summaries of business unit financial performance.
• Manage or perform periodical or ad hoc financial data analysis, queries, reconciliations, and reports to satisfy external client or audit requests.
• Support initiatives targeted at financial processes improvement and implementation of changes to achieve efficiencies in project billing, contract compliance and reporting, indirect cost recovery, financial reporting, and analysis.
• Support mergers and acquisitions with financial analysis and integration.
• Work collaboratively with the CFO and VP of Finance and report to the VP of Finance.
• Perform other duties as assigned.

Regulatory Affairs Specialist

Associate Director, FP&A