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Principal Software and Security Compliance Audit Specialist - Remote
Remote / Online - Candidates ideally in
Boulder, Boulder County, Colorado, 80301, USA
Listed on 2025-12-27
Boulder, Boulder County, Colorado, 80301, USA
Listing for:
Medtronic
Remote/Work from Home
position Listed on 2025-12-27
Job specializations:
-
IT/Tech
Cybersecurity, Data Security
Job Description & How to Apply Below
Employer Industry: Medical Device Technology
Why consider this job opportunity:- Salary up to $
- Eligible for the Medtronic Incentive Plan (MIP) for short-term bonuses
- Comprehensive benefits package including health, dental, and vision insurance, tuition assistance, and retirement plans
- Opportunities for career advancement within a global leader in healthcare technology
- Supportive work culture focused on innovation and collaboration
- Commitment to diversity and inclusion in the workplace
- Manage and oversee internal audit activities related to regulated medical device software and product cybersecurity
- Remain informed on regulatory requirements and identify gaps in medical device software
- Conduct internal assessments and audits in accordance with regulatory standards
- Develop training programs for Software as a Medical Device (SaMD) and product cybersecurity
- Analyze audit data and present findings to management and regulatory bodies
- Bachelor’s degree with 7+ years of experience in Quality or regulated industry, or an advanced degree with 5+ years of experience, or a PhD with 3+ years of experience
- Subject matter expertise in regulated medical device software and product cybersecurity
- Experience in Quality/Compliance and/or Audit with medical device requirements
- Strong understanding of software and product cybersecurity development lifecycle processes
- Ability to analyze complex issues and improve existing methods
- Experience with relevant software development or product cybersecurity engineering
- Familiarity with IEC 62304, ISO 13485, and FDA device software guidance
- Security certifications such as CISSP, CEH, or CISA
- Experience auditing Quality Systems to global requirements
- Strong interpersonal communication and collaborative work style
#Medical Device #Healthcare Technology #Cybersecurity #Audit #Career Growth #Innovation
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