Careers at ThermoFisher Scientific

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Job ID :
Location :
US - Kansas - Lenexa
Job Description

Position Summary:
Responsible for assisting in preparation, implementation, conformance and verification of Company quality policies and Regulatory Affairs procedures in compliance with 21 CFR Part 820 Quality System Regulations, ISO 9000 series standards, all domestic and foreign import/export regulations, Thermo Fisher Scientific RA Compliance programs, and applicable International standards.

Key Responsibilities:

  • Develop, maintain and monitor programs for compliance with the Quality Systems Regulations and internal procedures.
  • Assist the Quality Systems Manager in the preparation and control of regulatory documents.
  • Prepare and control documents in support of product recalls and field actions.
  • Prepare and submit all required Submissions to Foreign Governments.
  • Input all information as necessary for new products including but not limited to formulation, processing and labeling data for product manufacturing.
  • Review/approve documents including Device Requests, Label Copy, Device Master Records, Document Control Changes, Standard Operating Procedures Review promotional information and product literature to ensure regulatory compliance.
  • Review governmental rulings to determine changes and probable effects on facility activities.
  • Input all information as necessary for new products including but not limited to formulation, processing and labeling data for product manufacturing.
  • Perform maintenance as necessary to existing product information.
  • Participate as team member in Vendor, Customer, and Parent Company Audits. Participate in general review and update of Standard Operating Procedures according to Food & Drug Administration Quality System Regulations, ISO, and internal procedures.
  • Perform duties in accordance with established company procedures and policies; perform other duties as assigned.
  • Listen to and follow verbal and written instruction given in the English language.
  • Report any actual or potential safety hazards to the Supervisor, Human Resources, Safety Specialist or Senior Management.

Minimum Requirements/Qualifications:
  • Possess a B.S. degree, preferably in a biomedical field.
  • Possess prudent and practical decision-making abilities, good written and verbal communication skills, and ability to work independently without direct supervision.
  • Prefer knowledge of FDA, Medical Devices, and ISO regulations for device manufacturing.
  • Knowledge of proper grammar/English/spelling and journalism skills to create and/or edit documents from oral, written or transcribed draft information.
  • Basic math skills.
  • Possess excellent verbal and written communication skills.
This position is not approved for relocation assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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