Senior Compliance Engineer

Description

• Acting as primary SME (Subject Matter Expert) in internal and external audits for your assigned products
• Creating the Risk Management Plan and performing safety and security risk analysis in collaboration with the Software Engineering and Medical Affairs teams
• Managing product requirement specifications and traceability matrices
• Leading technical design reviews for new product introductions and product updates
• Producing robust release documentation to meet change management requirements
• Performing post-market risk assessments on product defects and incidents
• Evaluating third party software libraries and tools for inclusion in our software development
• Drafting gap analyses to new or updated regulations and standards
• Revising QMS procedures to improve compliance or efficiency of our processes

Qualifications

• BS/MS in any engineering or scientific discipline. Computer science preferred. No hands-on coding experience is needed.
• At least 4-5 years of working in the medical device or pharmaceutical industry, preferably in medical device product development.
• At least 3-5 years of experience in audits with criteria such as ISO 13485, EU MDR, MDSAP, HDS, SOC2, HITRUST and other regulatory frameworks.
• Proficiency in producing technical analysis/reports, including ability to learn about and understand clinical pathways.
• Thorough understanding of medical device regulations and standards.
• Solid technical knowledge of the software development lifecycle and common industry tools and methods.
• Basic familiarity with privacy laws (EU GDPR, CCPA, HIPAA)