171904 - Clinical Specialist - WI
Industry
PRO
Region
WI-Wisconsin
City
Milwaukee
State
WI
Rate
$54.35 to $57.97 DOE
Duration
6 months
Description
Chipton Ross is seeking a Clinical Specialist in Milwaukee, WI.

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

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.

Requirements:
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 Must have active Valid Current nursing license
Ideal Candidate:
Charge Nurse, ER Nurse

Education:
o BS/BSN or local equivalent

Schedule:
Full-time/40 hours

Contact
Billy James at bjames@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x340 or (800) 927-9318 x340

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.