Labeling Specialist - Regulatory Affairs
Company: PROCEPT BioRobotics Corporation
Location: Redwood City
Posted on: June 6, 2021
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
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
- Develop and write the labelling content for current and new
- Research and interpret labeling regulations, standards and
- Assist in providing labeling guidance and actively
participate/collaborate with cross-functional teams
- Coordinates outsourced labeling activities such as
- Execute ECOs as needed for labeling release.
- Assists in continuous improvement to labeling process.
QUALIFICATIONS (Education, Experience,
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
Qualifications / Skills Required
- Bachelors degree in a scientific or engineering
- Minimum of 2 years experience in working in a technical writing
/ labeling position
- Knowledge of International medical device labeling standards is
- Familiarity with document or content management systems is
- Proficiency in basic computer skills, including Microsoft
Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
- Strong organization skills, able to manage multiple projects
- Excellent oral and written communication skills
- Ability to work independently as an individual contributor and
in a team environment
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
- 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.
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
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Keywords: PROCEPT BioRobotics Corporation, Redwood City , Labeling Specialist - Regulatory Affairs, Other , Redwood City, California
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