Full-Time

Associate Regulatory Labeling Specialist

Posted on 10/29/2024

PROCEPT BioRobotics

PROCEPT BioRobotics

501-1,000 employees

Develops robotic solutions for BPH treatment

Biotechnology
Healthcare

Compensation Overview

$86k - $108kAnnually

+ Annual Bonus + Equity/RSUs

Entry

No H1B Sponsorship

San Jose, CA, USA

Hybrid on-site/local WFH acceptable.

Category
Risk & Compliance
Legal & Compliance
Required Skills
Adobe Illustrator
Graphic Design
Requirements
  • Bachelor’s degree, in scientific or engineering field preferred
  • Excellent written communication skills, especially with technical information
  • Precise, thorough and analytical
  • Proactive and adaptable to a fast-paced work environment, including managing multiple projects simultaneously
  • Open to recent graduates, especially those with relevant internship experience
  • Advanced degree or credential in regulatory affairs preferred
  • Up to three (3) years work experience in medical device or other regulated industry preferred
  • Familiarity with graphic design software and/or desktop publishing software preferred
Responsibilities
  • Design graphic content for label artwork using design software, such as Adobe Illustrator, as well as dedicated labeling software, such as Bartender
  • Draft written content for product inserts, using desktop publishing software such as Adobe InDesign
  • Apply style guidelines and branding standards to new and modified product labeling
  • Verify that labeling complies with all applicable requirements
  • Create and revise label items within the company’s document control system, by drafting and releasing engineering change orders
  • Represent the Labeling department on project teams by collecting potential labeling inputs from other departments; interpreting the impact that projects, such as design changes, will have on labeling content; and implementing necessary modifications to the product labeling

PROCEPT BioRobotics develops robotic solutions specifically for treating benign prostatic hyperplasia (BPH), a condition that affects many older men by causing prostate enlargement and urinary issues. Their main product, the AquaBeam Robotic System, utilizes Aquablation therapy, which combines real-time imaging, robotics, and waterjet technology to precisely remove prostate tissue in a minimally invasive manner. This system is designed for use by urologists and healthcare facilities, focusing on improving patient outcomes and making surgical procedures more efficient. Unlike competitors, PROCEPT BioRobotics emphasizes predictable results and reduced complications, which has led to their technology being recognized in clinical guidelines. The company's goal is to enhance the quality of life for patients suffering from BPH through advanced surgical solutions.

Company Stage

IPO

Total Funding

$319.1M

Headquarters

Redwood City, California

Founded

2009

Growth & Insights
Headcount

6 month growth

9%

1 year growth

28%

2 year growth

102%
Simplify Jobs

Simplify's Take

What believers are saying

  • Expansion into prostate cancer treatment could open new markets and revenue streams.
  • Significant investments provide capital for global expansion and product development.
  • Growing real-world evidence supports Aquablation therapy's long-term benefits and adoption.

What critics are saying

  • Increased competition from Intuitive Surgical and Medtronic may impact market share.
  • Reliance on AquaBeam System means technical failures could affect reputation and finances.
  • FDA trials for prostate cancer treatment introduce regulatory risks if standards aren't met.

What makes PROCEPT BioRobotics unique

  • PROCEPT offers a unique Aquablation therapy for BPH, using waterjet technology.
  • The AquaBeam Robotic System provides image-guided precision in minimally invasive urologic surgery.
  • Aquablation therapy is effective regardless of prostate size, shape, or surgeon experience.

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