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Clinical Specialist
Ref No.: 18-07212
Location: Milwaukee, Wisconsin
Start Date: 06/13/2018
Job Description:
Job Title: Clinical Specialist Department: Quality Assurance Travel Required
Minimal Position Type: Regular Exempt or Non Exempt Exempt
Reports To: VP of Global Quality Assurance & Regulatory Affairs Direct Reports to this position: None Geographic location: Milwaukee Position

Summary: The Clinical Specialist utilizes their clinical experience to help evaluate patient safety risk during pre-market risk assessments and post-market issues.
Position Responsibilities: • 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. • Assists the Complaint Handling Unit (DCU) with writing regulatory rationales for complaint closure. • Provides clinical input for Engineering during pre-market risk assessment. • Identifies patient and/or user risks related to environmental and/or medical device use/workflows; assists with identification of existing or potential mitigations. • Provides clinical input for Design Quality Assurance during post-market risk assessments. • Provides clinical input during the evaluation of other non-conformances, such as software anomalies and nonconforming material, where needed. • Provides clinical training for company personnel on products, clinical markets and use environments. • Reviews and approve quality system documents that require clinical input. • Perform other duties as requested. Essential competencies: • BS/BSN or local equivalent • 3+ years of relevant experience • Desired experience is medical device or drug manufacturing environments. • Desired knowledge of FDA, European regulatory or Quality System requirements. • Preferred clinical experience includes cardiac care, surgery or emergency experience. • Excellent communication skills, written and verbal. • Competence in Microsoft Office applications and database systems. • Strong analytical skills. • Ability to work independently and as part of a team. • Proactive and timely in execution of assigned tasks. • Able to be flexible and adaptable when needs and priorities change • Ability to work under minimal supervision. • Ability to work in a fast paced high stress environment and remain calm under pressure. • Ability to collaborate in a multidiscipline environment. • Attention to details and maintain comprehensive documentation. • Good organization and planning skills. Physical demands and work environment: Physical Demands: None – general office environment. Work environment: None – general work environment.

Mandatory Skills:
Must have active Valid Current nursing license
Charge Nurse, ER Nurse