Clinical Software Audit Manager
Boston ScientificHighlight
Summary
About the Role
About You
- 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 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.
- Minimum of 3 years' experience in a managerial or leadership role within clinical, auditing, quality assurance, or regulatory compliance.
- Proven knowledge of design change evaluation, supplier quality assurance, and IT security assessment for third-party vendors.
- Demonstrated ability to implement innovative solutions and leverage technology to improve auditing processes.
Benefits
- Competitive salary range of $82.1k–$156k.
- Access to the latest tools, information, and training to advance skills and career.
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and follow us on Instagram, Facebook and YouTube. At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers. You may also review our social media guidelines at http://www.bostonscientific.com/social.