Instrument Compliance Specialist - Axelon Services Corporation
Durham, NC 27703-8481
About the Job
Instrument Compliance Specialist
Durham, NC
12 Months
Actual Job Title: Instrument Compliance Specialist
Job Responsibilities:
" Participate in product design discussions/reviews to ensure product requirements are met for diagnostic products.
" Identify relevant product safety/compliance requirements for new designs and build appropriate regulatory strategy for project team implementation.
" Evaluate design change controls and identify applicable safety/compliance standards.
" Monitor and understand changes to compliance standards and communicate impact to marketed products as well as products in development.
" Working closely with certification bodies as primary contact in projects and life cycle maintenance
Experience and Background:
" Bachelor s Degree in engineering (e.g. electrical or machinery), alternative general science, chemistry, biology, etc. or equivalent
" Minimum 5 years experience in field
" Knowledge of ISO/IEC standard requirements (e.g. IEC 61010-1 Safety Compliance, ISO 12100 Risk Assessment and ISO 13849-1 Safety of Control Systems of Machinery )
" Familiarity with EU NLF (CE marking) and other EU Regulations
" Experience working in Quality Management System (e.g. ISO 9001) beneficial
" Strong working background in Design Control and Technical Documentation
Technical Skills Requirements:
Understanding of Machinery/diagnostics development process and regulatory requirements desirable.
Durham, NC
12 Months
Actual Job Title: Instrument Compliance Specialist
Job Responsibilities:
" Participate in product design discussions/reviews to ensure product requirements are met for diagnostic products.
" Identify relevant product safety/compliance requirements for new designs and build appropriate regulatory strategy for project team implementation.
" Evaluate design change controls and identify applicable safety/compliance standards.
" Monitor and understand changes to compliance standards and communicate impact to marketed products as well as products in development.
" Working closely with certification bodies as primary contact in projects and life cycle maintenance
Experience and Background:
" Bachelor s Degree in engineering (e.g. electrical or machinery), alternative general science, chemistry, biology, etc. or equivalent
" Minimum 5 years experience in field
" Knowledge of ISO/IEC standard requirements (e.g. IEC 61010-1 Safety Compliance, ISO 12100 Risk Assessment and ISO 13849-1 Safety of Control Systems of Machinery )
" Familiarity with EU NLF (CE marking) and other EU Regulations
" Experience working in Quality Management System (e.g. ISO 9001) beneficial
" Strong working background in Design Control and Technical Documentation
Technical Skills Requirements:
Understanding of Machinery/diagnostics development process and regulatory requirements desirable.
Source : Axelon Services Corporation