Key skills
Risk ManagementChange ManagementCollaboration
About this role
Role Overview
- 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
Requirements
- BS/MS in any engineering or scientific discipline. Computer science preferred.
- 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)
Benefits
- A supportive environment that focuses on people development and best practices
- Opportunity to design, influence, and be innovative
- Work with global teams and share new ideas
- Be supported both inside and outside of the work environment
- The opportunity to build something meaningful and seeing a direct impact on people's lives