California Jobs
Analyst, Post Market Surveillance
California Jobs, Stockton, California, United States, 95202
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics, and biotechnology? At Cepheid, one of 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact.
You will thrive in a culture of belonging where your unique viewpoint matters. By harnessing Danaher's system of continuous improvement, you help turn ideas into impact—innovating at the speed of life.
Cepheid is passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a team member, you'll make an immediate, measurable impact on a global scale in an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world's most complex health challenges. Together, we bring more change to the world.
Position Overview
The Analyst, Post-Market Surveillance, manages the adverse event process for Cepheid. Responsibilities include assessing complaints for reportability decisions to regulatory authorities, submitting Vigilance and Medical Device Reporting globally. The role collaborates with Medical and Scientific Affairs, Risk Management, and Post Market Surveillance teams, providing growth opportunities within Post Market Quality and other related functions. Key Responsibilities
Ensure complete and accurate maintenance and timely reporting of Adverse Event Reports (MDR, MIR, etc.) as required by regulatory agencies. Understand current and upcoming Adverse Event reporting requirements and ensure proper implementation. Partner with Complaint-Handling personnel to ensure complaint records contain all required information for regulatory compliance. Determine reportability of complaints in collaboration with Medical and Scientific Affairs, Risk Management, and cross-functional teams. Collect and analyze post-market data; write PMS reports and PSURs. Minimum Requirements
Bachelor's degree with 5+ years of related experience or Master's degree with 2+ years of related experience. Knowledge of Quality, Regulatory Compliance, GMP, and QSR requirements (ISO 13485, FDA's QSRs, EU's MDD, Canadian Regulations). Self-directed with strong prioritization skills. Excellent written communication, interpersonal, negotiation, and problem-solving skills. Team player with mentoring experience. Preferred Qualifications
Experience with Post Market Surveillance, IVDR, or MDR. Experience using Salesforce.com. Our benefits include health insurance, paid time off, 401(k), and bonus potential. The salary range is $74,000 - $115,800, with eligibility for incentives. We are committed to diversity and equal opportunity in the workplace.
#J-18808-Ljbffr
The Analyst, Post-Market Surveillance, manages the adverse event process for Cepheid. Responsibilities include assessing complaints for reportability decisions to regulatory authorities, submitting Vigilance and Medical Device Reporting globally. The role collaborates with Medical and Scientific Affairs, Risk Management, and Post Market Surveillance teams, providing growth opportunities within Post Market Quality and other related functions. Key Responsibilities
Ensure complete and accurate maintenance and timely reporting of Adverse Event Reports (MDR, MIR, etc.) as required by regulatory agencies. Understand current and upcoming Adverse Event reporting requirements and ensure proper implementation. Partner with Complaint-Handling personnel to ensure complaint records contain all required information for regulatory compliance. Determine reportability of complaints in collaboration with Medical and Scientific Affairs, Risk Management, and cross-functional teams. Collect and analyze post-market data; write PMS reports and PSURs. Minimum Requirements
Bachelor's degree with 5+ years of related experience or Master's degree with 2+ years of related experience. Knowledge of Quality, Regulatory Compliance, GMP, and QSR requirements (ISO 13485, FDA's QSRs, EU's MDD, Canadian Regulations). Self-directed with strong prioritization skills. Excellent written communication, interpersonal, negotiation, and problem-solving skills. Team player with mentoring experience. Preferred Qualifications
Experience with Post Market Surveillance, IVDR, or MDR. Experience using Salesforce.com. Our benefits include health insurance, paid time off, 401(k), and bonus potential. The salary range is $74,000 - $115,800, with eligibility for incentives. We are committed to diversity and equal opportunity in the workplace.
#J-18808-Ljbffr