Job Listing Description

Clinical Specialist - WI

Chipton Ross is seeking a Clinical Specialist in
Milwaukee, WI.

Job Description: The Clinical Specialist utilizes their clinical experience to help evaluate patient safety risk during pre-market risk assessments and post-market issues.

Position Responsibilities:
o Reviews potentially reportable complaints that have been escalated by the Complaint Handling Unit (DCU) and determine if an adverse event should be reported to regulatory agencies.
o Assists the Complaint Handling Unit (DCU) with writing regulatory rationales for complaint closure.
o Provides clinical input for Engineering during pre-market risk assessment.
o Identifies patient and/or user risks related to environmental and/or medical device use/workflows; assists with identification of existing or potential mitigations.
o Provides clinical input for Design Quality Assurance during post-market risk assessments.
o Provides clinical input during the evaluation of other non-conformances, such as software anomalies and nonconforming material, where needed.
o Provides clinical training for company personnel on products, clinical markets and use environments.
o Reviews and approve quality system documents that require clinical input.
o Perform other duties as requested.

Essential competencies:
o BS/BSN or local equivalent
o 3+ years of relevant experience
o Desired experience is medical device or drug manufacturing environments.
o Desired knowledge of FDA, European regulatory or Quality System requirements.
o Preferred clinical experience includes cardiac care, surgery or emergency experience.
o Excellent communication skills, written and verbal.
o Competence in Microsoft Office applications and database systems.
o Strong analytical skills.
o Ability to work independently and as part of a team.
o Proactive and timely in execution of assigned tasks.
o Able to be flexible and adaptable when needs and priorities change
o Ability to work under minimal supervision.
o Ability to work in a fast paced high stress environment and remain calm under pressure.
o Ability to collaborate in a multidiscipline environment.
o Attention to details and maintain comprehensive documentation.
o Good organization and planning skills.

o BS/BSN or local equivalent

o As needed/on call

Job Number: 170135
Job Location: Milwaukee, WI
Rate: $30 to $35.71 DOE
Duration: 6 months
Input Date: 05/11/2018
Attention: Billy James
Address: 343 MAIN ST
City, State: EL SEGUNDO, CA 90245
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808

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