Analyst, Post Market Surveillance
Analyst, Post Market Surveillance
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.
At Cepheid we are passionate about improving health care through fast accurate molecular diagnostic systems and tests. As a member of our team youll get to make an immediate measurable impact on a global scale within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the worlds most complex health challenges. Together we bring MORE change to the world.
Learn about the Danaher Business System which makes everything possible.
The Analyst Post-Market Surveillance is responsible for managing the adverse event process for Cepheid. This includes assessing complaints cross functionally for reportability decisions to regulatory authorities i.e. submitting Vigilance and Medical Device Reporting globally. The role will collaborate closely with Medical and Scientific Affairs Risk Management and Post Market Surveillance teams and you will learn about diagnostic therapies clinical impacts to patients and latest Post Market Surveillance requirements. You will have growth opportunities within Post Market Quality and other Quality related functions.
This position reports to the Sr. Manager Regulatory Compliance and Post Market Surveillance and is part of the Post-Market Quality team located in Sunnyvale CA OR Lodi CA and will be an on-site role.
In this role you will have the opportunity to:
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 by regulatory bodies and ensure adequate implementation
Partner with Complaint-Handling personnel to assure the complaint records contain all required information to make a compliant regulatory decision
Determine reportability of complaints collaborating with Medical and Scientific Affairs Risk Management and other cross functional teams.
Collect and analyze post-market data and write PMS reports and PSURs.
The essential requirements of the job include:
Bachelors degree with 5 years of related work experience OR Masters degree in field with 2 years of related work experience.
Functional knowledge of Quality Regulatory Compliance and operations systems and processes to include GMP and QSR requirements for medical devices. (ISO 13485 FDAs QSRs EUs MDD Canadian Regulations) is required.
Possess essential skills for self-directed manner prioritizing workload and responsibilities.
Strong written communication interpersonal negotiations and problem-solving skills.
Exceptionally strong team player with excellent interpersonal and experience working with end-users in a mentoring capacity.
It would be a plus if you also possess previous experience in:
Experience in Post Market Surveillance requirements with IVDR or MDR.
Experience using Sales .
Cepheid a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
The annual salary range for this role is $74000 - $115800. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.
#LI-LCS
Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.
For more information visit .
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 to request accommodation.
Required Experience:
IC
Employment Type
Full-Time
