Instrument Compliance Specialist - GTT, LLC

Durham, NC 27703-8481

Instrument Compliance Specialist

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 business objectives and veterinary diagnostic and BioDevices development projects, regulatory change management, and/or routine regulation and compliance maintenance.
The 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 the stakeholders, partner groups, suppliers, and customers.

Job Responsibilities:

Instrument Compliance Specialist participates 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 strategies 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

Required 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 the 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 the Machinery/diagnostics development process and regulatory requirements is desirable.

Benefits:

About the Company:

As the world’s leading animal health company, our client is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After 70+ years of innovating ways to predict, prevent, detect, and treat animal illness, they continue to stand by those raising and caring for animals worldwide - from livestock farmers to veterinarians and pet owners. The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics, and technologies make a difference in over 100 countries. A Fortune 500 company, they generated revenue of $7.8 billion in 2021 with ~12,100 employees.
Our client’s Colleagues foster a “run it like you own it” mindset and know their decisions and actions make a direct impact on our business and our customers. They have a highly collaborative culture and work across the business as one team to get results that matter.

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Source : GTT, LLC