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26 days old

Risk Specialist

Kelly Services
Sunnyvale, CA 94086
**Senior Risk Specialist- Sunnyvale, CA (remote)**


**OVERVIEW:**


+ The Risk Specialist is responsible for supporting the risk management process and generating risk management deliverables in accordance with FDA and ISO regulations. This position is part of the Quality Assurance team and will be located remotely.


**RESPONSIBILITIES:**


+ Independently planning, coordinating, and maintaining product risk management files for post market sustainment.

+ Performing post launch risk assessments for product performance issues identified through complaints.

+ Collaborating with cross functional teams such as Medical and Scientific Affairs, Post Market Quality, Regulatory Affairs, and Operations.


**REQUIREMENTS:**


+ Bachelors Degree in Microbiology, Biomedical/Bioengineering, or related discipline

+ 3+ years related experience for Senior Level

+ Open to 1-3 years experience for more junior level role

+ Experience with IVD

+ Experience of performing and leading risk assessments following ISO 14971 guidance


**PREFERRED SKILLS:**


+ Experience with Agile

+ Basic understanding of molecular biology


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-04-29 Expires: 2022-06-20

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Risk Specialist

Kelly Services
Sunnyvale, CA 94086

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