Job Description
JOB TITLE: REGULATORY AFFAIRS SPECIALIST I
JOB LOCATION: 250 S KRAEMER BLVD, BREA, CA 92821, USA
PAY RATE RANGE: BETWEEN ($28/HR ON W2 TILL $38/HR ON W2)
JOB DESCRIPTION/COMMENT:
Plans, coordinates, facilitates, and reports on CLIENT regulatory programs.
RESPONSIBILITIES MAY INCLUDE:
Administration of the company’s complaint management program for compliance to corporate requirements - Assist in the planning and implementing pre-market registration, reporting and compliance activities in accordance with the business plans.
Assists in the implementation of global regulatory compliance programs for product corrective action and/or adverse event reporting.
Assist in the preparation of premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.
EDUCATIONAL REQUIREMENTS:
Bachelor’s degree in field with 2+ years exp. OR Master’s degree in field with 1+ years exp. IVD experience strongly desire.
Qualifications
250 S Kraemer Blvd, Brea, CA 92821, USA
Additional Information
PAY RATE RANGE: BETWEEN ($28/HR ON W2 TILL $38/HR ON W2)