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Labeling Specialist - Regulatory Affairs

Company: PROCEPT BioRobotics Corporation
Location: Redwood City
Posted on: June 6, 2021

Job Description:

PROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the companys AquaBeam Robotic System delivering Aquablation therapy, is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size, or surgeon experience.
   

SUMMARY
As Procept continues to grow and widen its global footprint the Regulatory Affairs team now needs to hire a talented Labeling Specialist to provide labeling expertise for new and existing robots from development through marketing approval and commercialization.  You will be responsible for the definition and generation of Labeling and for the development/revision of procedures and practices to ensure compliance with FDA and international regulations, guidelines, and standards for labeling. In addition, you will bring your collaboration skills to provide labeling expertise and guidance to our project teams.
The initial role of the Labeling Specialist will be as an individual contributor and you will report to the Director of Global Regulatory Affairs.

CORE RESPONSIBILITIES (Other duties may be required as assigned)

  • Develop and write the labelling content for current and new product introductions.
  • Research and interpret labeling regulations, standards and guidance.
  • Assist in providing labeling guidance and actively participate/collaborate with cross-functional teams
  • Coordinates outsourced labeling activities such as translations.
  • Execute ECOs as needed for labeling release.
  • Assists in continuous improvement to labeling process.

QUALIFICATIONS (Education, Experience, Certifications) 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
Qualifications / Skills Required

  • Bachelors degree in a scientific or engineering discipline. 
  • Minimum of 2 years experience in working in a technical writing / labeling position
  • Knowledge of International medical device labeling standards is preferred.
  • Familiarity with document or content management systems is preferred.
  • Proficiency in basic computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
  • Strong organization skills, able to manage multiple projects and timelines
  • Excellent oral and written communication skills
  • Ability to work independently as an individual contributor and in a team environment

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

  • To perform this duty the employee must have the ability to sit or stand at and operate a computer terminal and walk or travel safely within the facility. The employee may occasionally lift and/or move up to 15 pounds. 

WORK ENVIRONMENT
While performing the duties of this job, the employee regularly works in an office environment. 


The above statements are intended to describe the general nature and level of work being performed.
They are not intended to be construed as an exhaustive list of all responsibilities.

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Keywords: PROCEPT BioRobotics Corporation, Redwood City , Labeling Specialist - Regulatory Affairs, Other , Redwood City, California

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