Job Description

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Description

Job Summary
The Labeling Coordinator participates to cross functional projects as the PLD representative; leading labeling activities and support the project team to define the labeling needs and requirements in accordance with established standards and templates, review project documentation; assess necessary resources and estimate timelines for documentation development, review and translation.

Using design control processes, define labeling requirements to provide traceability for project development projects and use change management processes to maintain existing product ranges. Additionally, provide follow-ups for all PLD related activities needed to fulfill the project/change request. Track and coordinate instructions for use translations, identifying scope of languages and timeline needs. Interact with the local translation coordinator (labeling support) to maintain timelines.

The Labeling Coordinator shall communicate effectively and accurately with internal customers and management to ensure that timelines and objectives are achieved.

Participate on demand to internal/external audit preparation or audit to explain labeling activities for their respective projects.

- Bachelor degree in technical writing/communication or a scientific/technical degree.

Skills and Qualifications:

• Demonstrate subject ownership and communication
• Project management experience (e.g.: project planner, project management tools )
• Quality standards a plus
• Knowledge of labeling procedures, regulations, and
• Minimum 2 years of Professional experience in product documentation development is essential. Medical devices or other regulated environment strongly recommended. Knowledge of development and change management processes.

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant\'s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics\' application process by contacting us via telephone at (385) 770-1132, by email at , or by dialing 711 for access to Telecommunications Relay Services (TRS).

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