Regulatory Affairs Specialist I
Job ID :
US - Kansas - Lenexa
- 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.
- 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 9000 series, 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.
In addition, other duties may be assigned as the need arises.
- B.S. degree, preferably in a science or computer field.
- Experience with Microsoft Office Suite programs.
- Preferred three years of experience in quality, product reliability, and/or product development in a quality, manufacturing environment.
- Preferred knowledge of FDA, Medical Devices, and ISO regulations for device manufacturing.
- Possess prudent and practical decision-making abilities.