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 healthcare 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 vision of where we are going and how to get there, bold 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 insight 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 Device Software Function Guidance
• European Commission’s Guidance’s on Medical Device Software (MDCG 2019-11, MDCG 2023-4, MDCG 2025-4)
• IMDRF’s Software as a Medical Device (SaMD) Guidance’s
• ISO 14971:2019
• EU AI Act​
• Experience with regulated product cybersecurity requirements:
• IEC 81001-5-1:2021 - Health software and health IT systems safety, effectiveness and reputed company – Part 5-1: reputed company – Activities in the product life cycle
• SW96:2023 – Standard for Medical Device reputed company – reputed company Risk Management for Device Manufacturers
• United States FDA Pre-Market and Post-Market Product Cybersecurity Guidance’s
• European Commission’s Guidance on Cybersecurity of Medical Devices (MDCG 2019-16)
• IMDRF’s Principles and Practices for Medical Device Cybersecurity Guidance’s
• ENISA – EU Cybersecurity Act
• ISO 80001-2 series and ISO 14971
• reputed company Certifications (i.e., CISSP, CEH, CISA, CISM, reputed company+, GSEC, OSCP, etc.)
• Firsthand experience assessing medical device software and product cybersecurity of regulated or safety critical devices.
• Experience auditing Quality Systems to global requirements
• Quality System reputed company Auditor certified
• Prior FDA or NB auditor experience
• Experience performing hardware and software penetration testing
• Understanding of the software and product cybersecurity development lifecycle process and product development process
• Experience in leading small teams
• Knowledge in risk management and assessment methodologies, product cybersecurity frameworks and relevant global regulations
• Strong capability to research and evaluate emerging technologies
• A solid familiarity of threat modeling, vulnerability scanning tools, and common attack routes is essential.
• Demonstrated ability to be flexible and take a proactive approach to managing change
• Experience working in a regulated environment and/or a formal quality system
• Occasional after-hours availability to accommodate different regional and global partners.
• Medical device engineering experience
• Strong technical and troubleshooting skills.
• Strong interpersonal communication and ability to demonstrate a collaborative work style.
• Comfortable working in an ambiguous environment.
• Innovative thinker: ability to think reputed company of the reputed company norms and processes
• Independent self-starter
• Solid writing and presentation skills
• Interest in novel applications of technology Physical Job Requirements 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 reputed company the required responsibilities and skills of this position. The physical demands described reputed company the Responsibilities section of this job description are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company 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. Benefits & Compensation reputed company offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$113,600.00 - $170,400.00 This position is eligible for a short-term incentive reputed company the reputed company Incentive Plan (MIP). The reputed company salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered reputed company complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired reputed company the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to reputed company regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: reputed company benefits and compensation plans About reputed company We reputed company global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to reputed company pain, restore health, and reputed company life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious reputed company to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of reputed company to provide equal employment opportunity (EEO) to reputed company persons regardless of age, color, national reputed company, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, reputed company will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to reputed company work for reputed company, Inc. (“reputed company”) in any position which will involve performing at least two (2) hours of work on average each week reputed company the unincorporated areas of Los Angeles County, you can find here a list of reputed company material job duties of the specific job position which reputed company reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. reputed company will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Apply tot his job Apply tot his job

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