Senior Regulatory Affairs Labeling Specialist

PROCEPT BioRobotics Corporation; United States; On-site; USD 122,000 - 143,000; Full time

Job summary

PROCEPT BioRobotics Corporation is seeking a Senior Regulatory Affairs Specialist (Labeling) to lead global labeling activities, author content for manuals and on-product labeling, and ensure compliance with 21 CFR and EU MDR standards. The role partners with engineering, marketing, manufacturing and legal to drive labeling projects to completion.

The ideal candidate brings 5+ years in medical device regulatory affairs, strong documentation skills, and proficiency with labeling software and

Qualifications

• Bachelor’s degree in a scientific or engineering field.
• 5+ years in medical device regulatory affairs.
• Knowledge of 21 CFR 800-1299 and FD&C Act.
• Experience with EU MDR/IVDR is a plus.
• Experience maintaining labeling content and IFUs.

Responsibilities

• Lead regulatory labeling activities for global submissions.
• Author content for User Manuals, product inserts, and on-product labeling.
• Provide SME input on global labeling requirements and standards.
• Apply branding standards to new or modified labeling.
• Verify labeling compliance with regulatory requirements.
• Manage external design providers for label artwork via Illustrator or Bartender.
• Create and revise label items in document control systems.

Skills

Regulatory labeling

Global regulatory submissions

Labeling content creation

Cross-functional collaboration

Adobe Illustrator

Microsoft Office

Attention to detail

Education

Bachelor’s degree in scientific or engineering field

Advanced regulatory degree or credential preferred

Tools

Adobe Illustrator

Bartender

Labeling software

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

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.

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
• 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
• Experience with e-labeling applications and/or content management system applications preferred
• Fluent in graphic design software and/or desktop publishing software

Pay Range for this role: $121,890 to $143,400

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. 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!