Clinical Software Audit Manager

Additional Location(s): US-MN-Maple Grove; US-MA-Marlborough

The Clinical Software Audit Manager oversees the assessment, qualification, and auditing of clinical, software, and pre‑clinical vendors to ensure all Boston Scientific products and services meet international regulatory requirements and internal quality standards. This role oversees the full audit lifecycle—from planning, vendor categorization, and risk management to corrective action—while collaborating with cross‑functional teams to drive continuous improvement and support innovative clinical research and digital health initiatives.

The role serves as a subject matter expert for Real World Data/Evidence providers and Digital Health Technology solutions, enhancing transparency and compliance across all vendor engagements.

At Boston Scientific, this role follows a hybrid work model requiring employees to be in our local office in Maple Grove, MN or Marlborough, MA at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

• 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.

• 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…