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Cutera Inc.
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**Clinical Adverse Event Specialist**
* Brisbane, CA
* Full-time
* Position Type: Exempt
**Company Description**
Cutera (NASDAQ: CUTR) is a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide. The company is growing faster than its peers and offers very competitive compensation and benefits packages that include 401(k) matching and stock equity for US employees.
**Job Description**
**Position Summary:** The primary responsibilities of the Clinical Adverse Event Specialist are to interact with customers to address questions and concerns regarding adverse events to Cutera device treatments, to learn and document all details that may have contributed to the adverse event, and to report reportable adverse events and serious incidents to the appropriate regulatory authorities.
**Specific Duties and Responsibilities:**
Contacting customers (device users, user facilities, patients, or distributors) within 2 business days of receiving each new report of an adverse event or incident related to a Cutera device treatment and interacting with the customers to address their questions and concerns.
Using good faith efforts to obtain, document, and evaluate all available information related to each report including, but not limited to, the device involved, procedure performed, device settings, error messages reported during the procedure, patient photographs prior to and at various timepoints following the event, and the results of field service and/or factory inspections of the device involved.
When needed, timely submission of mandator reports to global regulatory agencies.
Maintaining files of all adverse event and incident reports received from customers.
Participation in internal and external audits of Cutera's adverse event files providing detailed information for the files sampled and justifications for reportability decisions made.
Summarizing reportable and non-reportable adverse event and incident data for presentation in biannual Management Review Meetings.
Other duties as assigned.
**Qualifications**
Minimum of 3 years hands-on experience delivering laser and/or energy-based treatments as a nurse, esthetician, or equivalent. Prior experience with Cutera devices is preferred but not required.
Prior experience in medical device complaint management and/or adverse event investigation and regulatory agency reporting is a strong plus.
Strong verbal and written communication skills, including the ability to interact with and reassure Cutera customers and patients who may be stressed and/or upset.
Strong computer skills, preferably including experience working with Salesforce.com.
Demonstrated ability to create and defend concise and accurate reports.
Demonstrated commitment to quality and strong sense of teamwork.
**Additional Information**
All your information will be kept confidential according to EEO guidelines.
If you are ready to become part of our spectacular, growing, and FUN company, then apply today!
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
*Applicants responding to this posting must be able to provide proof of eligibility to work in the United States. Competitive salary, benefits, ESPP and stock options. Cutera is an Equal Employment Opportunity Employer.*
If you are ready to become part of our spectacular, growing, and FUN company, then apply today!
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
*Applicants responding to this posting must be able to provide proof of eligibility to work in the United States. Competitive salary, benefits, ESPP and stock options. Cutera is an Equal Employment Opportunity Employer.*
Clinical Adverse Event Specialist
* Brisbane, CA
* Full-time
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