Responsibilities
- Audit focus will be primarily medical device software, product cybersecurity, and risk management.
- Manage and oversee 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 security knowledge and maintain insight into current industry best practices and how they can be applied to Medtronic.
- 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 security enhancement.
- Possess understanding of Software Bill of Material (SBOM) development and maintenance for the purposes of vulnerability monitoring.
- Possess an understanding of non-probabilistic scoring methodologies for security 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 related to regulated medical device software and product cybersecurity risks.
- Enable strong partnerships across the organization to drive best-in-class regulated medical device software and product cybersecurity development.
- Analyze complex issues and significantly improve, change, or adapt existing methods.
- Show creativity and innovation in all aspects of your responsibilities.
Additional Information
- Expected travel: 20-25%
- The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
- The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile.
- The employee is also required to interact with a computer, and communicate with peers and co-workers.
- Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
