ARC-One Solutions

Compliance

• Oversees the planning, execution, and monitoring of quality and regulatory activities to ensure organizational compliance
• Leads and develops a high‑performing compliance team by setting priorities, managing performance to activity, and supporting professional development
• Serves as the quality knowledge expert in all related to a SaMD organization and the primary point of contact for the Agile Release Train (ART) and Compliance Teams
• Works collaboratively with the ART and management team members to align quality and compliance activities with business and product goals
• Promotes Lean-Agile product development principles integrates them into the Quality Management System using a risk-based approach
• Identifies, assesses, and communicates quality and compliance risks, providing actionable recommendations to improve product quality and regulatory readiness
• Drives continuous improvement initiatives to maintain adherence to Standard Operating Procedures (SOPs), regulatory requirements, and quality standards
• Leads the creation, review, approval, and maintenance of quality documentation
• Plans and manages quality management projects that support ongoing compliance and continuous improvement
• Establishes, monitors, and reports on post-market quality metrics
• Manages the internal audit program, guiding internal auditors and ensuring overall organizational compliance
• Facilitates external audits and inspections, including Food and Drug Administration (FDA), client, and other regulatory audits, to ensure successful outcomes
• Ensures execution of regulatory operations, including standards maintenance, product labeling, Unique Device Identifier (UDI) updates, and medical device reporting requirements.

Compliance Manager

Database Administrator

• Oversees daily operations of production, non-production and redundant database environments on the cloud and on-premises implementations
• Formulates policies, procedures, and standards relating to database management and monitors transaction activity and utilization
• Reviews database design and integration of systems and makes recommendations regarding enhancement and/or improvements
• Develops, manages and tests back-up and recovery plans ensuring that all procedures are functioning properly
• Maintains security and integrity controls over the databases
• Contributes to the development of a strategy for use of relational databases technology
• Advises organization leaders on database concepts and functional capabilities and recommends system changes to programming staff.