Analyst, Post Market Surveillance

Danaher Corporation • Sunnyvale, CA • 3d ago

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 Danaher's (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's 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, you'll 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 world's most complex health challenges. Together, we bring MORE change to the world.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/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 l ocated 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:

Bachelor's degree with 5+ years of related work experience OR Master's 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, FDA's QSRs, EU's 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 Force Dot Com.

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

The annual salary range for this role is $74,000 - $115,800. 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 Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

LI-LCS

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's 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 www.danaher.com .

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 (https://www.dol.gov/agencies/ofccp/posters) .

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 applyassistance@danaher.com to request accommodation.

Operating Company: Cepheid

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