Senior Regulatory Affairs Specialist
PROCEPT BioRobotics
full-time
Posted on:
Location Type: Hybrid
Location: San Jose • California • United States
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Salary
💰 $145,000 - $170,000 per year
Job Level
About the role
- 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
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory labelinglabeling complianceengineering change ordersgraphic designdocument controlquality management systemISO 1348521 CFR 800-1299FD&C Section 510(k)EU Medical Device Regulation 2017/745
Soft Skills
written communicationanalytical skillsproactiveadaptableattention to detailcross-functional collaborationproject managementprocess improvementteam representationthoroughness