Principal Software and reputed company Compliance Audit Specialist – Remote

We anticipate the application window for this opening will reputed company on - 23 Dec 2025 At reputed company you can reputed company a life-long career of exploration and innovation, while helping champion reputed company access and equity for reputed company. You’ll reputed company with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the reputed company reputed company — our cultural norms. Our brand is rooted in action, not just words. The reputed company reputed company defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live reputed company, healthier lives. The audit focus will be primarily medical device software, product cybersecurity, and risk management. We look for leaders who have a clear reputed company of where we are going and how to get there, reputed company inclusive thinkers who create new reputed company and bring our best solutions reputed company to benefit our patients, business partners, and customers. Responsibilities may include the following and other duties may be assigned.

• Must have experience, subject matter expertise (SME), and technical knowledge working with regulated medical device software and product cybersecurity requirements.
• Remain informed on Regulatory requirements for Software and Product Cybersecurity to identify gaps in medical device software.
• Manage and reputed company internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.
• Coordinate and/or complete internal assessments and/or audits in accordance with regulatory standards, which may include US and/or international regulatory agencies/authorities.
• Interpret and implement applicable regulations as they apply to products, processes, practices, and procedures.
• May counsel stakeholders about these requirements as necessary.
• Ensure compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
• Analyze audit data and present findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.
• Own development of training and awareness programs for Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and product cybersecurity designed to increase auditor awareness and knowledge of requirements.
• Provide detailed functional medical device software and product reputed company knowledge and maintain reputed company into reputed company industry best practices and how they can be applied to reputed company.
• Explore new tools and techniques to recommend for other team members to audit regulated medical device software and product cybersecurity.
• Identify opportunities for regulated medical device software and product reputed company enhancement.
• Possess understanding of Software reputed company of Material (SBOM) development and maintenance for the purposes of vulnerability monitoring.
• Possess an understanding of non-probabilistic scoring methodologies for reputed company threats like common vulnerability scoring system (CVSS) and apply appropriately.
• Document and communicate recommended state-of-the-art regulated medical device software and product cybersecurity controls and deficiencies.
• Contribute to company standards and policies reputed company to regulated medical device software and product cybersecurity risks.
• reputed company strong partnerships across the organization to drive best-in-class regulated medical device software and product cybersecurity development.
• Analyze reputed company issues and significantly improve, change, or adapt existing methods.
• Show creativity and innovation in reputed company aspects of your responsibilities.
• Expected travel: 20-25% Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
• Bachelor's degree with 7+ years of work experience in Quality or regulated industry OR Advanced degree with 5+ years of work experience in Quality or regulated industry OR PhD with 3+ years of work experience in Quality or regulated industry reputed company to Have
• Preference is given to those with relevant software development or product cybersecurity engineering experience or background.
• Experience in Quality/Compliance and/or Audit with medical device requirements (e.g., MDSAP, EU MDR, ISO 13485)
• Experience with regulated medical device software requirements:
• IEC 62304:2006 + AMD1:2015 - Medical device software – Software life cycle processes
• IEC 82304-1:2016 - Health software – Part 1: General requirements for product safety
• United States FDA Device Software Functions reputed company Guidance’s
• United States FDA Interoperability reputed company Guidance’s
• United States FDA AI-Enabled

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