Apply knowledge of risk management to ensure a risk-based approach for design and process activities
Review and approve engineering change orders
Support customer requests (internal and external)
Support new product introduction for Sources and Detectors
Maintain and update technical files and risk management files to comply with global regulations
Participate in addressing audit findings
Support internal audits and external audits by regulatory agencies, as required.
Your Profile:
Bachelors Degree in life sciences, preferably in Electronic or Mechanical engineering
Minimum of 3 years of work experience with a focus on design control, risk management, and verification and validation.
2+ years of global experience in regulatory affairs or quality assurance medical device, aerospace, defense or similarly regulated industry
Background with Medical Devices (ISO 13485), Electrical Medical Devices (ISO 60601), Risk Management ISO 14971, or Pharmaceutical.
Expertise and understanding to analyse the meaning of regulations for the business.
Understanding of safety requirements in this industry context.
Understanding of Quality Assurance management and experience in reviewing engineer change orders.
Basic knowledge of ERP systems and Microsoft software.
Strong verbal and written communication skills; ability to present issues, plans and objectives. Excellent organizational, problem solving, and analytical skills
Fluent communication in English.
Ability to lead priorities and workflow versatility, flexibility, and a willingness to work within constantly evolving priorities
Ability to collaborate with global team members
Additionally valued qualities:
Experience with the application of Data Science and Advanced Statistical Techniques
Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA s General Principles of Software validation.