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Regulatory Compliance Coordinator
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Job Description

We currently have an opening for a Regulatory Compliance Coordinator to join for customer's team at a Medical Device company located in South San Jose. If you are a motivated, ambitious, performance driven candidate who enjoys a fast-paced, family friendly culture, this might be the perfect opportunity for you! Serious Inquiries only. 

GENERAL DESCRIPTION:



General Description:

Responsible for timely coordination and execution of post market regulatory compliance activities such as complaint handling, MDR/MDV filings, field actions and competent authority inquiries.  May make recommendations or decisions on the above as required. 

 

Essential Functions:

  • Document, follow-up on, and close product complaints as reported from various sources
  • Work with engineering groups to ensure product investigation is complete and accurate
    • Review complaint records prior to closure to ensure records are compliant with all relevant regulatory requirements
    • Review complaints for potentially reportable adverse event status, including evaluation and follow-up regarding MDR/MDV reporting
    • Complete complaint investigations and MDR/MDV reports within internal and regulatory timelines
    • Work from verbal and/or written instructions
    • Knowledge of applicable international regulations and standards (QSR, MDD, ISO 13485, CMDCAS, etc.) and willingness to train others in quality assurance/GMP-related topics
    • Develop and maintain positive relationships with regulatory agencies through professional oral and written communications
    • Communicate directly with customers and regulatory agencies regarding reported complaints and resolutions
    • Work with other departments on known and emerging issues to make quality improvements
    • Document, follow-up on, and close product field actions as required

 


Job Requirements

 

QUALIFICATIONS:

  • High school diploma required, Associate’s and/or Bachelor’s degree (B.S. or B.A.) preferred

•     Must be able to communicate effectively (verbal and written) with high customer service

•     Previous work experience in regulated industry preferred

•     Proficient in Microsoft Office (Word, Excel or Access, PowerPoint)

•     Strong detail orientation and ability to meet deadlines.  Planning and organization skills a must

•     Ability to work in team environment, but also self-starter with ability to work independently

•     Strong critical thinking and problem solving skills
*** Must be able to pass a thorough background check including education verification, and an instant drug screen. 


Job Snapshot

Base Pay $19.00 - $26.00 /Hour
Employment Type Full-Time
Job Type Admin - Clerical
Education High School
Experience 1 to 5 years
Manages Others No
Industry Biotechnology
Required Travel None
Job ID RCC
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Regulatory Compliance Coordinator


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