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27 days old

Clinical Safety and Performance Clinician

Kelly Services
West Chester, PA 19381
**Clinical Safety and Performance Clinician**




Kelly Services has an opening for a Clinical Safety and Performance Clinician in West Chester, PA to support EUMDR regulatory decisions for reportability. The Customer Quality Clinician is responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and Health Authority reporting. These activities include making regulatory reporting decisions for Vigilance and FDA. The Customer Quality Regulatory Clinician works collaboratively with Medical Safety, Customer Quality Engineering, Manufacturing, Product Development and other functional experts to assist in regulatory assessments and/or to support the Reportable Malfunction List. This individual is knowledgeable regarding regulations and standards affecting Medical Devices (e.g. ISO9001/13485/14971/14001, FDA Regulations (21CFR (803, 806, 820, part 11, etc.). This is a one-year assignment and may require up to 10% travel, including potential international.




**Qualifications**




+ The following degrees will be considered for this role: Biomedical engineering degree or a bachelors degree in Nursing, Life Sciences or Health Sciences is required or 6-8 years of related industry experience.

+ A minimum of 6 years of professional experience is required; a minimum of 4 years in a GMP and/or ISO regulated industry strongly preferred.

+ A current RN license or an advanced practicing license (i.e. PA, APRN, etc.) is strongly preferred. RAC or ASQ certifications are preferred.

+ Experience in post market regulatory, quality or compliance areas.

+ The ability to work independently and prioritize with little supervision is required.

+ Strong written and oral communication and interpersonal (listening) skills is required.

+ The ability to lead efforts aimed at the identification of problematic situations, reporting issues, and the development of resolutions and decision making is required.

+ Analytical and critical thinking skills are required.

+ Excellent organizational and time management skills are required.

+ Strict attention to detail is required.

+ Familiarity with basic quality tools and techniques is preferred.





If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!





**Perks of being a Kelly employee:**




+ Weekly electronic pay

+ Access to more than 3,000 online training courses though Kelly Learning center

+ Group rate insurance options available immediate upon hire*

+ Service bonus plan and holiday pay*

+ Online application system

+ Never an applicant fee





*perks to be received upon meeting eligibility requirements





**Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com**






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



With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
Posted: 2019-07-29 Expires: 2019-08-29

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Clinical Safety and Performance Clinician

Kelly Services
West Chester, PA 19381

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