Technical Specialist & Scheme Manager- General Devices
BSI Group
USA, United States
Base: $120,000 to $154,000 annually; bonus/equity:...
Fully remote
Medical device ce marking expertise
Iso 13485 qms assessment
Regulatory compliance knowledge
BSI is a designated European Notified Body and accredited ISO 13485 certification body with nearly 120 years of excellence and innovation
Job Summary
BSI is a designated European Notified Body and accredited ISO 13485 certification body with nearly 120 years of excellence and innovation.
This home-based position involves delivering technical reviews, scheme management, and providing regulatory advice to improve patient safety.
BSI offers a competitive salary, comprehensive benefits including health, dental, disability, 401k match, paid holidays, and paid time off.
Matching Summary
BSI is a designated European Notified Body and accredited ISO 13485 certification body with nearly 120 years of excellence and innovation.
Salary
Base: $120,000 to $154,000 annually; Bonus/Equity: Not specified; Benefits: Group-sponsored health and dental, disability, 401k match, life insurance, paid holidays and PTO
Skills & Requirements
Must-have
Medical Device CE Marking expertise
ISO 13485 QMS assessment
Regulatory compliance knowledge
Medical device design and development
Risk management and design control
Home-based with up to 25% travel
Nice-to-have
Analytical and communicative skills
Leadership and mentoring abilities
Technical sales and networking support
Curiosity and diligence
Client-centric and collaborative mindset
Key Requirements
Bachelor's degree or higher in relevant discipline
At least 5 years post-graduate medical device experience
Knowledge of medical device regulations
Awareness of certification business processes
Experience with quality management standards and audits