Title: Clinical Specialist RN
Duration : 6+ Months contract
Location : Milwaukee, WI 53224
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.
- 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.
Must have active Valid Current nursing license
Charge Nurse, ER Nurse