Job summary
Job post source
This job is directly from Cepheid, a Danaher operating company.
Job overview
The Analyst, Post Market Surveillance at Cepheid manages adverse event processes to ensure regulatory compliance and patient safety in molecular diagnostics.
Responsibilities and impact
The role involves assessing complaints for regulatory reportability, maintaining adverse event reports, collaborating with cross-functional teams, and preparing post-market surveillance reports.
Compensation and benefits
The position offers an annual salary range of $74,000 - $115,800, eligibility for bonus/incentive pay, and comprehensive benefits including paid time off, medical/dental/vision insurance, and 401(k).
Experience and skills
Candidates need a Bachelor's degree with 5+ years or a Master's with 2+ years related experience, knowledge of quality and regulatory systems like GMP, QSR, ISO 13485, strong communication and teamwork skills; experience with Post Market Surveillance, IVDR or MDR, and Salesforce is a plus.
Career development
The role provides growth opportunities within Post Market Quality and other quality-related functions.
Work environment and culture
Cepheid fosters a culture of belonging, continuous improvement, diversity, and inclusion, emphasizing innovation and impact in life sciences.
Company information
Cepheid is a Danaher operating company focused on fast, accurate molecular diagnostic systems that improve global health care.
Team overview
The position is part of the Post-Market Quality team reporting to the Sr. Manager Regulatory Compliance and Post Market Surveillance, located in Sunnyvale or Lodi, CA.
Job location and travel
The job is on-site in Sunnyvale, CA or Lodi, CA.
Unique job features
The job offers unique exposure to regulatory compliance in diagnostics, collaboration with medical/scientific teams, and involvement in global post-market surveillance reporting.
Company overview
Cepheid is a molecular diagnostics company specializing in the development, manufacturing, and commercialization of fully integrated systems for testing in clinical and non-clinical settings. They generate revenue through the sale of diagnostic tests and instruments, particularly their GeneXpert system, which offers rapid, accurate molecular testing for infectious diseases, genetic disorders, and cancer. Founded in 1996, Cepheid has been a pioneer in the field of molecular diagnostics, and their technology played a crucial role in the rapid testing for COVID-19 during the pandemic.
How to land this job
Tailor your resume to highlight your expertise in post-market surveillance, adverse event reporting, and regulatory compliance, emphasizing familiarity with FDA QSR, ISO 13485, and international medical device regulations.
Showcase your ability to collaborate cross-functionally with teams like Medical Affairs and Risk Management, and your experience analyzing post-market data and preparing surveillance reports such as PSURs.
Apply through multiple platforms including Cepheid’s corporate careers page, LinkedIn, and relevant job boards to maximize your application visibility and chances.
Connect with professionals working in Cepheid’s Post Market Quality or Regulatory Compliance teams on LinkedIn; open conversations by referencing recent regulatory changes or expressing your enthusiasm for Cepheid’s mission in molecular diagnostics.
Optimize your resume for ATS by incorporating keywords from the job description such as 'Adverse Event Reporting,' 'Post Market Surveillance,' 'Regulatory Compliance,' 'MDR,' 'IVDR,' and 'Quality Systems.'
Leverage Jennie Johnson's Power Apply feature to automate tailored applications, identify multiple application channels, and discover LinkedIn contacts to network with, freeing you to focus on interview preparation and skill enhancement.
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