You have the clinical experience and expertise necessary to help us develop and sell the best in aesthetic lasers—allowing our customers to discover their Beautiful.
Engineering

You understand that quality is a lifestyle—not an afterthought.  You’ll establish procedures and testing methods to ensure that our products meet and exceed all requirements. And you’ll work to perfect a zero-defect development process.

 

Clinical Nurse Investigator, Job #105-14

Location: Westford, MA

Job Purpose: The Investigator serves as a clinical specialist in coordinating the investigation of patient impact/adverse events reports to determine causality and resolution for the impact. This position will collaborate with the customer sites, clinical trainers, sales reps and other departments to collect, verify and report information about patient impact/adverse events. In addition to reviewing treatment parameters for appropriate use of Cynosure products, the Investigator will provide feedback to QA, RA and Clinical Departments to identify the need for additional product training and assessing the injury/adverse event resolution.

Key Responsibilities:

  • Investigate alleged adverse events by obtaining information from multiple sources including user and Field Service Engineers.
  • Document all investigation findings in Syteline system and assess findings to determine validity to report.
  • Utilize knowledge of laser and light based systems and associated terminology to determine appropriate resolution and closure of reported patient impacts/adverse events within the required time frame.
  • Document and present detailed findings to appropriate departments
  • Report patient impact/adverse events to appropriate regulatory agencies as required.
  • Coordinate review processes with other departments to prevent inappropriate utilization of resources; keep inter-dependent departments informed of planned review activity.
  • Form and provide recommendations regarding process improvements to streamline PI investigative process, handling and documentation.
  • Participate in regulatory audits.
  • The position may provide treatment consultation and education to external customers.
  • Stay abreast of current regulatory requirements for adverse event tracking and reportable events
  • Other duties as required.

Behavioral and Interpersonal:

  • Ability to manage investigations in a professional manner with an understanding for the level of urgency needed.
  • Proven ability to communicate with professional providers for investigative purposes and to record review findings in electronic database.
  • Excellent written and oral communication skills.
  • Self-motivated with the ability to carry out responsibilities to meet business needs in high volume, fast paced and rapidly changing environment.
  • Ability to present prevention, correction, and education to customer site in a clear, concise manner and make recommendations for effective change.
  • Ability to manage tasks on multiple projects concurrently and work well independently.

Education and Experience Requirements:

  • Registered Nurse (RN/BSN or equivalent) and current Nursing license required.
  • Basic knowledge of laser and light based systems; instructions for use, labeling, warnings, contraindications, and known complications.
  • Strong PC skills with demonstrated knowledge of MS Office applications.
  • Knowledge of FDA regulations a plus.

LOCAL CANDIDATES ONLY PLEASE
If interested, please apply here