Senior Regulatory Affairs Labeling Specialist at PROCEPT BioRobotics

San Francisco, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Surgical Robotics, HealthcareIndustries

Requirements

Bachelor’s degree, in scientific or engineering field preferred
Five (5)+ years work experience in medical device field
Excellent written communication skills, especially with technical information
Fluent in graphic design software and/or desktop publishing software
Precise, thorough and analytical
Proactive and adaptable to a fast-paced work environment, including managing multiple projects simultaneously
Work Authorization Status: Citizen / Permanent Resident (For US-Based Candidates Only)

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
Contribute to Labeling department process improvement initiatives
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

Skills

Key technologies and capabilities for this role

Regulatory AffairsProduct LabelingAdobe IllustratorBartenderAdobe InDesignDesktop PublishingLabel ArtworkTechnical WritingMedtech Compliance

Questions & Answers

Common questions about this position

What qualifications are required for the Senior Regulatory Affairs Labeling Specialist role?

A Bachelor’s degree in a scientific or engineering field is preferred, along with five-plus years of work experience in the medical device field. Excellent written communication skills, especially with technical information, fluency in graphic design software and/or desktop publishing software, and being precise, thorough, analytical, and proactive are also required.

What are the main responsibilities of this position?

Daily tasks include designing graphic content for label artwork using software like Adobe Illustrator and Bartender, drafting written content for product inserts with Adobe InDesign, applying style guidelines, verifying compliance, managing label items in the document control system, contributing to process improvements, and representing the Labeling department on project teams.

What is the salary or compensation for this role?

This information is not specified in the job description.

Is this a remote position, or is there a location requirement?

This information is not specified in the job description.

What does PROCEPT BioRobotics value in candidates for this role?

The ideal candidate is a motivated labeling professional with attention to detail, critical thinking, initiative, and creative flair, ready to contribute to department growth while advancing their understanding of regulatory compliance, technical content creation, and product development.

PROCEPT BioRobotics

Develops robotic solutions for BPH treatment

About PROCEPT BioRobotics

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 urologists and healthcare facilities, focusing on enhancing 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 improve the quality of life for patients suffering from BPH through advanced surgical solutions.

Redwood City, CaliforniaHeadquarters

2009Year Founded

$319.1MTotal Funding

IPOCompany Stage

Robotics & Automation, HealthcareIndustries

501-1,000Employees

Benefits

Health Insurance

401(k) Company Match

401(k) Retirement Plan

Paid Vacation

Paid Parental Leave

Paid Holidays

Wellness Program

Gym Membership

Risks

Competition from Intuitive Surgical and Medtronic may impact market share.

$175 million public stock offering could lead to shareholder dilution.

Reliance on AquaBeam System makes company vulnerable to technological failures.

Differentiation

AquaBeam Robotic System offers image-guided, minimally invasive urologic surgery.

Aquablation therapy provides effective outcomes regardless of prostate size or surgeon experience.

PROCEPT has over 100 peer-reviewed publications supporting Aquablation therapy's benefits.

Upsides

Increasing adoption of robotic-assisted surgeries boosts demand for AquaBeam System.

Global urology devices market projected to grow at 6.9% CAGR until 2030.

FDA's supportive regulatory environment favors innovative medical technologies like PROCEPT's.

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