Senior Regulatory Affairs Specialist at PROCEPT BioRobotics – San Jose, California

• 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.

• 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

For US-Based Candidates Only

Work Authorization Status: Citizen / Permanent Resident

For this role, the anticipated base pay range is $145, 000-170,000 per year.

Plus, eligibility for an annual bonus and equity/RSUs