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Post-Market Compliance Specialist
Company: Cepheid
Location: Sunnyvale, CA
Employment Type: Full Time
Date Posted: 08/26/2021
Expire Date: 09/25/2021
Job Categories: Information Technology
Job Description
Post-Market Compliance Specialist


  • Drive initiatives to improve business objectives related to 21CFR820 regulations (820.198, 820.200 and 803 reporting requirements)
  • Work with Field Action Board coordinator to ensure field activities, including Field Corrections, Field Actions and Field Notifications are handled in a compliant, complete and timely manner
  • Lead implementation and execution of electronic IT systems related to Field Actions and Adverse events
  • Assist in filing MDRs as-needed
  • Assist in the reporting of all Reportable events to the applicable Regulatory Agency.
  • Lead communication efforts within the field action process
  • Coordinate activities during product recall or adverse event reporting activities


Education or Experience (in years):

  • Bachelors degree in field with 3+ years of related work experience OR

Masters degree in field with 1+ years of related work experience

  • Understanding of quality and QS/RC compliance requirements in relationship to product performance and customer expectations.

When you join us, youll also be joining Danahers global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, youll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or applyassistance@danaher.comto request accommodation.

If youve ever wondered whats within you, theres no better time to find out.

Contact Information
Contact Name:
Company Name: Cepheid
Phone Number:
Contact Email:
Website: https://jobs.danaher.com/global/en/...
Company Description:

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