Principal Software and Security Compliance Audit Specialist - Remote

Overview

The Principal Software and Security Compliance Audit Specialist will lead efforts in ensuring compliance with regulatory requirements for medical device software and product cybersecurity, playing a crucial role in enhancing healthcare technology.

In Short

• Lead audits and assessments of medical device software.
• Ensure compliance with internal and external regulations.
• Analyze audit data and present findings.
• Develop training for Software as a Medical Device (SaMD).
• Coordinate internal audits and investigations.
• Maintain knowledge of cybersecurity best practices.
• Collaborate with stakeholders on compliance issues.
• Explore new tools for auditing medical device software.
• Manage audit activities and prepare reports.
• Travel up to 25% for audits and assessments.

Requirements

• Bachelor's degree with 7+ years in regulated industry or equivalent.
• Experience in medical device software and cybersecurity.
• Familiarity with ISO and IEC standards.
• Experience in auditing quality systems.
• Knowledge of risk management methodologies.
• Strong communication and interpersonal skills.
• Ability to work in a regulated environment.
• Experience with penetration testing is a plus.
• Certifications like CISSP or CISA preferred.
• Must be flexible and proactive in managing change.

Benefits

• Competitive salary and flexible benefits package.
• Health, dental, and vision insurance.
• 401(k) plan with employer contribution.
• Tuition assistance and reimbursement.
• Paid time off and holidays.
• Employee stock purchase plan.
• Short-term and long-term disability leave.
• Employee assistance program.
• Well-being programs.
• Incentive plans for eligible employees.