Reg Affairs Technician

Job Title: Reg Affairs Technician

Location: Carlsbad, CA

Duration: 6+ Months

Job Summary

This position is responsible for directing and conducting routine complaint investigations of medical devices specified by priority or special request according to methods established.

Principal Duties and Responsibilities

Performs and documents complaint investigations to established procedures.

Conducts lot verification to established procedures.

Performs product identification measurements to established print requirements.

Verifies product label information and contents to appropriate specifications

Organizes and reports Final Inspection results.

Exercises assigned responsibility for on-the-job training of less qualified personnel

Communicates with management and engineers concerning product defects

100 Total Percent (not to exceed 100%)

Individual percent’s should be greater than or equal to 5%. 

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence (i.e. KSAs) 

Thoroughly familiar with client products and manufacturing methods

Thoroughly familiar with product inspection methods and limitations of the inspection methods.

Able to perform detailed dimensional and cosmetic inspection techniques on products.

Must be able to read and understand blueprints, work instructions, engineering specifications and inspection documents

Must be able to communicate technical information, both verbal and written

Must have vision correctable to 20/20

Must be able to life in the 40 pound range

Must have demonstrated ability to use micrometers, calipers, scales and comparators

Must have ability to learn CMM use.

Must have demonstrated ability to use shop math techniques (addition, subtraction, multiplication, division of decimals and fractions). 

Must be able to work independently with minimal supervision

Education/ Experience Requirements

High School diploma or equivalent plus related inspection work experience, or equivalent combination of education and experience.

Must be able to pass a background and drug screen