Boston Scientific · 16 hours ago
Clinical Software Audit Manager
US-MA-Marlborough
Full-time
Hybrid
Mid, Senior Level
$82K/yr - $156K/yr
5+ years expBoston Scientific is a leader in medical science, committed to solving significant health industry challenges. The Clinical Software Audit Manager oversees the auditing and qualification of clinical and software vendors to ensure compliance with regulatory requirements and internal quality standards, while driving continuous improvement and supporting clinical research initiatives.
Health CareMedicalMedical Device
No H1B
Responsibilities
Lead and oversee periodic audits and qualification assessments for clinical, software, and pre-clinical vendors, verifying adherence to regulatory requirements (FDA, ISO 13485, IEC 60601, ISO 14155, 21 CFR Part 11, Computer Software Assurance) and Boston Scientific’s quality standards
Oversee the categorization of external vendors—including RWD and Digital Health Technology suppliers—and update global procedures to ensure proper categorization and risk levels are clearly defined for third-party providers to meet clinical and regulatory criteria
Examine supplier control documentation and change management processes, authorizing procedural changes as appropriate to ensure compliance requirements and best practices for electronic records and signatures are met
Develop and maintain audit tools, checklists, and timelines; implement and track corrective action plans, using metrics to identify trends and drive process improvements
Lead, mentor, and develop the software auditing team, facilitating training programs and fostering a culture of collaboration and continuous improvement in audit and IT security practices
Promote effective communication regarding types of clinical vendors, audit findings, and how vendor software affects clinical studies and research outcomes
Serve as a subject matter expert for RWD/Evidence providers and digital health solutions, developing questionnaires and walkthroughs to enhance transparency and traceability of data sources
Collaborate with R&D, Clinical, Sourcing, Supplier Controls, Software Quality Assurance, Regulatory Affairs, and Data Science teams to support vendor management, audit readiness, and compliance oversight
Support governance and corrective action management, ensuring that all issues are resolved in line with organizational and regulatory expectations
Qualification
Required
Minimum Bachelor's degree in computer science, engineering, life sciences, or a related field; advanced degrees preferred
Minimum of 5 years' experience auditing software and clinical vendors, with demonstrated expertise in regulatory compliance, software validation, and risk analysis
Strong background in ISO 13485, IEC 60601, FDA guidelines, ISO 14155, and 21 CFR Part 11
Demonstrated experience with audit tool development, metrics tracking, and process improvement
Minimum of 3 years' experience in a managerial or leadership role within clinical, auditing, quality assurance, or regulatory compliance
Proven ability to lead, mentor, and develop teams, fostering collaboration and continuous improvement
Strategic planning, process optimization, and organizational change leadership experience
Strong stakeholder engagement skills, with experience presenting to senior leadership and cross-functional teams
Proven expertise in governance, compliance oversight, and corrective action management
Advanced project management skills, including vendor oversight and multi-project coordination
Preferred
Proven knowledge of design change evaluation, supplier quality assurance, and IT security assessment for third-party vendors
Proven experience leading audits, managing corrective action processes, and mentoring teams
Proven ability to work effectively with diverse teams across clinical, technical, and regulatory domains
Demonstrated ability to implement innovative solutions and leverage technology to improve auditing processes. Skilled in analyzing existing workflows, identifying inefficiencies, and introducing best practices that enhance accuracy and efficiency in audit execution
Benefits
Compensation may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-24
2026-01-23
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