Instrument Compliance Specialist - LanceSoft Inc
Durham, NC 27703
About the Job
Actual Job Title: Instrument Compliance Specialist
Location: Durham, NC - Can be 1 week / month onsite rest will be working from home
Role Description
The position of Instrument Compliance Specialist within Global Diagnostics Regulatory Affairs will support global regulatory diagnostic and BioDevices with aspects of an assigned product portfolio associated with instrument compliance. This role will align with *** business objectives and veterinary diagnostic and BioDevices development projects, regulatory change management and/or routine regulation and compliance maintenance. Regulatory scope will include but is not limited to applicable instruments like analyzers, microscopes and centrifuges. Responsibilities include communication, interfacing between certification bodies during the development and maintenance process as well as working closely with the Quality, Regulatory, Commercial Development, Product Management and Engineering Departments throughout the product lifecycle, owning deliverables, and embracing priorities that align with the needs of *** stakeholders, partner groups, suppliers, and customers.
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 (Client 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.
Location: Durham, NC - Can be 1 week / month onsite rest will be working from home
Role Description
The position of Instrument Compliance Specialist within Global Diagnostics Regulatory Affairs will support global regulatory diagnostic and BioDevices with aspects of an assigned product portfolio associated with instrument compliance. This role will align with *** business objectives and veterinary diagnostic and BioDevices development projects, regulatory change management and/or routine regulation and compliance maintenance. Regulatory scope will include but is not limited to applicable instruments like analyzers, microscopes and centrifuges. Responsibilities include communication, interfacing between certification bodies during the development and maintenance process as well as working closely with the Quality, Regulatory, Commercial Development, Product Management and Engineering Departments throughout the product lifecycle, owning deliverables, and embracing priorities that align with the needs of *** stakeholders, partner groups, suppliers, and customers.
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 (Client 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 : LanceSoft Inc