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Job Title: QA Professional (Instrument Compliance Specialist)
Job Location: Durham, NC
Job Duration: 12 Months
Job Description:
#sczr2
Job Location: Durham, NC
Job Duration: 12 Months
Job 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 Client’s business objectives and veterinary diagnostic and BioDevices development projects, regulatory change management and/or routine regulation and compliance maintenance.
- 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
- 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
- Understanding of Machinery/diagnostics development process and regulatory requirements desirable.
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