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DATE ADDED: Thu 11/10/2018

Regulatory Assistant

San Carlos, USA
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COMPANY: MDR

Job Description

Seeking Regulatory Assistant for medical device research facility.

SPECIFIC DUTIES AND RESPONSIBILITIES:

Support and participate in all IACUC duties including:

- Screen protocols for completeness

- Assist clients when necessary on protocol development

- Distribute amendments and deviations as needed

- Prepare agendas and distribute protocols and other materials to IACUC members

- Send out annual progress report reminders to client

- Send out approval letters to clients

- Review all documentation before submitting to QA

- Maintain records of protocols and IACUC minutes of meetings

- Maintain records of procedures, program reviews and facility inspection reports

- Coordinate and schedule the IACUC monthly meetings

Maintain Quality Program

- Be involved in improving processes and implementation via SOP review, random document review, walkthrough, feedback from management, etc.

- Spot check animal holding facilities to verify all documentation during ongoing projects

- Serving as an information resource for investigators and IACUC members regarding status of protocols and GLP studies

- Support equipment scheduling calibration & maintenance program, maintain records

In addition to the above, the position is required to support the GLP Program as needed within the following areas:

NIH/IACUC - assurance requirements

USDA - bi-annual audits - unscheduled audits - license requirements

QA: - GLP Project notebook (Master Schedule), QA audits - Quarterly internal business unit/facility audits - Water quality monitoring - Equipment: oversight of scheduling calibration & maintenance, maintain records - Support GLP Report compilation and associated functions related to compilation (archiving, review, etc.) - Act as a member of QAU SOP: - document control - processing

Special Factors: Must be able to work independently, exercise good judgment, and use diplomacy and tact in dealing with internal and external customers. Background or coursework in quality assurance a plus.

Local Candidates Only, no relocation


Role: Regulatory Assistant
Job Type:
Location: San Carlos,

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