23 days old

Clinical Affairs Specialist 5

Berkeley, CA
**Clinical Affairs Specialist 5**

Locations:Berkeley, California

Job Family: Quality Management


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Strategic Procurement

**Requisition Number:** 222713

**Primary Location:** United States-California-Berkeley

**Assignment Category:** Full-time regular

**Experience Level:** Senior level

**Education Required Level:** Master's Degree

**Travel Required:** 20%

**Division Description:**


is a global technology powerhouse that has stood for engineering excellence,

innovation, quality, reliability and internationality for more than 165 years.

As a global technology company, Siemens is rigorously leveraging the advantages

that this setup provides. To tap business opportunities in both new and

established markets, the Company is organized in nine Divisions: Power and Gas,

Wind Power and Renewables, Energy Management, Building Technologies, Mobility,

Digital Factory, Process Industries and Drives, Healthineers and Financial


With 45,000 employees Siemens Healthineers is one of the worlds largest

suppliers of technology to the healthcare industry and a leader in medical

imaging, laboratory diagnostics and healthcare IT. All supported by a

comprehensive portfolio of clinical consulting, training, and services

available across the globe and tailored to customers needs. So that more

people can have a life that is longer, richer, and more filled with happiness.

For more information, please visit: http://www.usa.siemens.com/healthcare

**Job Description:**

The Sr. Clinical Affairs Specialist is responsible for devising and

executing strategies for clinical trials of Molecular In-Vitro Diagnostics

products. The clinical trials will be used to support Pre-Market Approvals

(PMA) or 510(k)s in the United States or the IVDD and/or the IVDR in the EU for

new or existing products. These trials are complex, usually consisting of

several sub-studies and multiple clinical sites.

Responsibilities include representing clinical affairs in strategic

projects, oversight of the timely execution and compliance of clinical trials,

and preparation of regulatory submissions.

The role requires monitoring of proposed regulations and guidance

documents related to clinical trials and ensuring that all clinical activities

remain compliant with these requirements. The individual will interact with

regulatory bodies to present clinical plans or clinical data in support of

product approvals. He/she will interface with Principal Investigators to

execute contracts so that clinical trials are performed within the required

time frame. Ideally, the candidate

should have an M.S. or Ph.D. in an area of life science, with a minimum of 10years of experience in the area of clinical trials and expertise in infectious

diseases. The candidate will collaborate

with other teams internationally to successfully deliver multiple PMA and

510(k) submissions simultaneously. The

role reports to the Head of Quality and Technology and is located in Berkeley,


**E** **du** **c** **ation and Experience**

+ An M.S.orPh.D, preferablyinareasoflifescience, engineering or equivalent

+ 10+ years of experience inclinical trials and regulatory submissions (PMA and 510k), supporting newproduct launches as well as product updates in the IVD or Molecular Diagnosticsfield

+ 5+ years of leadershipexperience, with proven track record of delivering projects on time andpromoting high performance behaviors within a team

+ Familiarity with international regulations for IVDClinical Trials and prior experience in the acquisition and management ofclinical trial samples

+ Prior experience working with cross-functionalproject teams, IRBs and business partners

+ Fluency with Microsoft Office and Microsoft Outlook


+ Agile and flexible team player with the ability tomeet project timelines and complete clinical affairs deliverables to meetglobal regulatory requirements related to clinical trials

+ Understanding of regulations and guidelinesgoverning the areas of medical device and in-vitro diagnostic development, witha broad knowledge of requirements and best practices in Clinical Affairs,Regulatory Affairs and Product Development

+ Proven ability to multitask, collaborate incross-functional teams, and work independently

+ Excellent communication skills and excellentEnglish writing skills, with the ability write clinical trial reports anddocumentation independently

+ Critical-thinker with excellent negotiation skillsand the ability to address complex situations independently, and the ability toadopt a systemic view of continuous process improvement to support businessgoals and decisions

+ Proven ability to manage multiple time-sensitivehigh priority projects

+ Ability to develop or revise clinical trialprocedures and processes

+ Willingness to travel up to 20%

**Pr** **eferredKnowledge/Skills, Education, and Experience**

+ Excellent relationshipswith a broad base of clinicians and laboratorians who can perform field orclinical trials and who have clinical populations appropriate for specimenacquisition

+ Direct Laboratoryexperience

+ Professionaldesignationsarenotrequired,buttrainingandcertificatesinqualityorregulatoryaffairsisaplus( _e.g_ _._ ,CQM,CQE,CQA,RAC,CLIA,SixSigma,LeanPrinciples)


**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, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

**EEO is the Law**

Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

**Pay Transparency Non-Discrimination Provision**

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .


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Clinical Affairs Specialist 5

Berkeley, CA

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