Senior Regulatory Affairs Labeling Specialist
5 days ago
San Jose
Job DescriptionCompany OverviewEmbark 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. The Opportunity That Awaits You: Help make our first impression the best that it can be. Our product labeling introduces the customer to our devices, before they’ve even left the box. 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 Regulatory Labeling Specialist 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 labeling 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: • 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, • Bachelor’s degree, in scientific or engineering field preferred, • Five (5)-plus 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 simultaneouslyThe Qualifications We Would Like You to Possess, • Advanced degree or credential in regulatory affairs preferred, • Experience with e-labeling applications and/or content management system applications preferred.