Clinical Software Audit Manager

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

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the role:

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. This 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.

Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. 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.

Your responsibilities will include:

• 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.

Required qualifications:

• 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 qualifications:

• 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.

Requisition ID: 621977 

Minimum Salary: $ 82100 

Maximum Salary: $ 156000 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles 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 for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.