Hybrid Senior Regulatory Affairs Specialist – Labeling

at PROCEPT BioRobotics

• Job title: Senior Regulatory Affairs Specialist – Labeling
• Job type: Full Time
• Experience level: Senior
• Salary: $120,000 - $144,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, San Jose, United States

About the role

• Senior Regulatory Affairs Specialist ensuring compliance for medical device labeling, managing regulatory project activities. Collaborating across functions to support global regulatory submissions in a medical device company.

Responsibilities

• 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.

Requirements

• 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

Benefits

• full medical coverage
• wellness programs
• on-site gym
• a 401(k) plan with employer match
• short-term and long-term disability coverage
• basic life insurance
• wellbeing benefits
• flexible or paid time off
• paid parental leave
• paid holidays