Clinical Affairs Specialist 2

at Siemens in Newark, Delaware, United States

Job Description

Now’s our time to inspire the future of healthcaretogether.

Healthineers is a leading global medical technology company with over 170 years
of experience and 18,000 patents. More than 48,000 dedicated
colleagues in over 70 countries are driven to shape the future of healthcare.
We stand with our customers around the world to support them in delivering high
quality care to their patients. An estimated 5 million patients across the
globe benefit every day from our innovative technologies and services in
the areas of diagnostic and therapeutic imaging, laboratory diagnostics and
molecular medicine, as well as digital health and enterprise services. This is
what truly matters to us.

our team now at Siemens Healthineers as Clinical Research Associate 2

This is a role well suited to an ambitiousprofessional, looking for the next step in their career. As a Clinical ResearchAssociate 2, you will be responsible for :

+ In your activities you will aid indesign and preparation of clinical and analytical in vitro diagnosticdevice performance study plans, protocols, and reports, statistical dataanalysis plans, and associated study data collection forms.

+ You will supervise study sites andactivities also during on-site visits to ensure adherence to protocols andterms of the study

+ You will communicate with studyinvestigators regarding activities in all phases of the studies includingstudy budgets, contracts and their approvals by compliance and IRBs

· You gained knowledge of in
vitro diagnostic product design and development and experience as a member of
product development core teams preferred.

· You are aware of US (21 CFR
820) and EU (ISO 13485) quality system requirements; Understands: Design
Control, Good Clinical Practice, In Vitro Diagnostic Regulation, Essential
Requirements, labeling requirements, and regulatory requirements of pertinent

· You show the ability to
work in a matrix organization with cross-functional teams.

· You show excellent
communication skills in person and virtually with presentations, both oral and

Required skills to have for thesuccess of this role

+ Bachelor’s degree or equivalentexperience required

+ Willing to travel up to 30%

Siemens Healthineers, we value those who dedicate their energy and passion to a
greater cause. Our people make us unique as an employer in the med-tech industry.
What unites and motivates our global team is the inspiration of our common
purpose: To innovate for healthcare,
building on our remarkable legacy of pioneering ideas that translate into even
better healthcare products and services. We recognize that taking ownership of
our work allows both us and the company to grow. We offer you a flexible and
dynamic environment and the space to move beyond your comfort zone to grow both
personally and professionally.

If you want to join us in transforming the way healthcareis delivered, visit our career site at .

you wish to find out more about the specific before applying, please visit: .

an equal-opportunity employer we are happy to consider applications from
individuals with disabilities.

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Experienced Professional

Job Type: Full-time

Equal Employment Opportunity Statement

Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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Applicants and employees are protected under Federal law from discrimination. To learn more, Click here ( .

Pay Transparency Non-Discrimination Provision

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here (\%20English\formattedESQA508c.pdf) .

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Job Posting: JC184219187

Posted On: May 22, 2021

Updated On: Jul 28, 2021