Senior Regulatory Affairs Labeling Specialist

PROCEPT BioRobotics

San Jose (CA)

On-site

USD 122,000 - 143,000

Full time

16 hours ago

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Job summary

PROCEPT BioRobotics is seeking a Senior Regulatory Affairs Specialist (Labeling) in San Jose, CA to lead labeling activities for global regulatory submissions. You will author content for manuals, labels, and inserts, and ensure compliance across US and international markets.

The role requires 5+ years in medical device regulatory affairs, knowledge of 21 CFR 801-1299 and EU MDR 2017/745, ISO 13485, and strong cross-functional collaboration with engineering, marketing, and legal teams.

Qualifications

Bachelor's degree in science or engineering required; advanced degree preferred.
5+ years in regulatory affairs for medical devices.
Knowledge of 21 CFR 801-1299; experience with 510(k).
Experience with EU MDR 2017/745.
ISO 13485 knowledge.
Strong cross-functional teamwork and communication.

Responsibilities

Lead regulatory labeling activities for global submissions and variations.
Authorship for User Manuals, product inserts, and labeling content.
Advise on global labeling requirements and ensure compliance with standards.
Manage external providers for label artwork using Illustrator and Bartender.
Create and revise label items in the document control system; issue changes.
Contribute to labeling process improvements and project collaboration.

Skills

Regulatory labeling

Global submissions

Content authoring

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in science or engineering

Advanced degree (preferred)

Tools

Adobe Illustrator

Bartender

MS Office

Job description

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

Understanding PROCEPT’s Culture

At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism.

We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.

And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.

An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!

The Opportunity That Awaits You

Help make our first impression the best that it can be. This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets for product labeling activities. No product can be complete without comprehensive, clear, and compliant labels. As part of the team that ensures our labels meet the user’s needs, the Senior Regulatory Affairs Specialist (Labeling) will work closely with other departments across the organization, making this a position that offers a unique breadth of exposure to different medtech compliance and design functions. The ideal candidate is a motivated regulatory professional ready to contribute to the growth of the department while continuing to advance their own understanding of regulatory compliance, technical content creation, and product development. Succeed in this role with your attention to detail, critical thinking, initiative, and creative flair.

What Your Day-To-Day Will Involve

Lead regulatory labeling activities in support of global regulatory submissions for product registrations and variations.

Lead authorship responsibilities for content within User Manuals, product inserts, and on-product labeling.

Provide SME input on global regulatory labeling requirements and standards. Apply style guidelines and branding standards to new and modified product labeling. Verify that labeling complies with all applicable requirements

Manage external service providers in designing graphic content for label artwork using design software, such as Adobe Illustrator, as well as dedicated labeling software, such as Bartender

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 Regulatory Affairs labeling function 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.

The Qualifications We Need You To Possess

Bachelor’s degree, in scientific or engineering field preferred

Five (5)-plus years work experience in medical device field

Minimum of 5 years’ experience working in regulatory affairs in a medical device company

Knowledge of Title 21 of the US code of Federal Regulations (21 CFR 800-1299)

Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k)

Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) and EU Medical Device Regulation 2017/745

Experience with Quality Management System Standard ISO 13485 is required

Experience working cross-functionally with engineering, marketing, manufacturing, and legal teams to facilitate completion of labeling and artwork assignments

Excellent written communication skills, especially with technical information

Proficiency in Microsoft Office Suite preferred

Precise, thorough and analytical

Proactive and adaptable to a fast-paced work environment, including managing multiple projects simultaneously

The Qualifications We Would Like You To Possess

Advanced degree or credential in regulatory affairs preferred

Hands-on experience maintaining Instructions for Use (IFUs), product labels, capital equipment documentation, and packaging labels in compliance with regulatory standards and internal labeling requirements