ADVERSE EVENT SPECIALIST

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 responsibility of the Adverse Event Specialist is to lead and coordinate timely investigation into all potentially reportable incidents, adverse events, and device malfunctions related to Cutera manufactured or distributed medical devices and to report those determined to be reportable to the appropriate regulatory agencies.

Specific Duties and Responsibilities :

Leading and coordinating timely investigation of all complaints related to potentially reportable incidents, adverse events, and device malfunctions.

Initiating investigations by contacting the device user, user facility, patient, distributor, importer, and / or originator within 2 business days of receiving each new complaint.

Using good faith efforts to obtain and evaluate all available information related to each complaint including the device, procedure, device settings, operator experience, error messages reported during the procedure, photographs of alleged injury, etc.

Sharing non-HIPPA protected data with engineering and / or quality as needed to assist in RMA device evaluation and root-cause determination.

Documenting each investigation fully including the triggering complaint, investigation actions taken, investigation findings, and the reportability decision.

When needed, timely submission of mandator reports to global regulatory agencies.

Participation in Notified Body, MDSAP, and other regulatory agency audits of Cutera's Complaint files, including providing detailed event information for Complaints sampled and justifications for reportability decisions made.

Summarizing reportable and non-reportable adverse event data for presentation in biannual Management Review Meetings.

Other duties as assigned.

Qualifications

Nursing background (RN, NP, or equivalent) with a minimum of 3 years hands-on laser or energy-based medical device experience, preferably including Cutera products.

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.*

Adverse Event Specialist

• Brisbane, CA
• Full-time
30+ days ago