Senior Staff Regulatory Affairs Associate # 4333

Responsibilities:

• Lead and manage internal processes and systems, clinical and diagnostic quality audits, as well as investigator sites and service provider audits and gap assessments.
• Identify areas of compliance vulnerability in both clinical and CDx pipelines, develop and drive corrective/preventive action plans, and track clinical compliance-related metrics for senior leadership.
• Provide routine clinical compliance support to clinical study, and CDx project teams, ensuring adherence to ICH E6 (GCP), relevant diagnostic regulations, and internal quality standards.
• Support and, where necessary, lead risk assessment and mitigation strategies for clinical studies and CDx programs.
• Lead and continuously refine the organization’s inspection readiness framework for clinical studies and companion diagnostic development, spanning global and regional regulatory inspections (e.g., BIMO, pre-approval, GCP, CLIA, IVDR).
• Conduct inspection readiness training and coaching sessions 
• Serve as the primary point of contact for hosting inspections/audits, drafting and tracking responses to findings, driving resolution, and leading post-inspection lessons-learned initiatives.
• Revise, develop, and maintain procedures within the Clinical Quality Management System, leveraging lessons from inspections, audits, and emerging clinical compliance trends, in both GCP and CDx domains.
• Contribute to, implement, and continuously improve quality management policies and processes related to clinical studies, laboratory-developed tests, and companion diagnostic programs.
• Own and maintain GCP audit program SOPs and templates, ensuring they remain current with evolving regulatory requirements and industry best practices.
• Review and provide compliance advice on SOPs, processes, and protocols for both clinical trial and companion diagnostic activities, ensuring consistency and compliance with relevant GCP, CLIA, FDA/IVDR, and other global diagnostic regulatory requirements.
• Serve as a resource and subject matter expert on clinical and companion diagnostic regulatory standards and best practices.
• Provide leadership, expertise, and guidance in clinical and companion diagnostic compliance to internal and external stakeholders.
• Promote a culture of quality and clinical compliance, proactively identifying compliance risks and embedding best practices into organizational processes.
• Collaborate with cross-functional teams (e.g., Regulatory, Quality Assurance, Lab Operations, Clinical Data Management, etc.), and senior leaders to establish inspection norms and foster continuous improvement.

Preferred Qualifications:

• Bachelor’s degree or higher in a scientific, health, quality, or regulatory discipline (advanced degree preferred)
• 10 + years relevant experience in clinical quality assurance, diagnostics, and/or regulatory compliance within the diagnostics, or medical device field.
• Experience supporting regulatory inspections such as BIMO. Demonstrated experience managing GCP and/or CDx inspection and audit preparation and response.
• Expert knowledge of applicable regulations and standards as they relate to clinical trial conduct
• Understanding of appropriate global medical device/IVD requirements, such as: ICH E6 (GCP), European Union (ISO 20916, ISO 14155, IVDD/IVDR), US [21 CFR Part 812 and Part 11].
• Experience managing GCP quality processes such as managing Quality Events and CAPAs; and participating in risk management activities.
• Conducting GCP audits of internal processes, clinical investigator sites, and clinical service vendors.
• Demonstrated ability to initiate process improvements and take initiative.
• Strong influencing skills, with the ability to work collaboratively and cross functionally, within a constantly evolving  fast-paced startup environment.
• Ability to drive and manage change with a positive approach.
• Travel of up to 20%