Senior Regulatory Affairs Specialist (Labeling) (Medtech)

TL;DR

Senior Regulatory Affairs Specialist (Labeling) (Medtech): Leading global regulatory labeling activities and authorship of technical documentation for surgical robotics with an accent on compliance with FDA and EU MDR standards. Focus on managing the end-to-end labeling lifecycle, ensuring technical accuracy in user manuals, and coordinating with cross-functional design and engineering teams.

Location: Hybrid in San Jose, CA. Must be a US Citizen or Permanent Resident.

Salary: $120,000 - $144,000 per year

Company

hirify.global is dedicated to revolutionizing the treatment of benign prostatic hyperplasia (BPH) through innovative surgical robotics.

What you will do

• Lead regulatory labeling activities for global product registrations and variations.
• Author content for User Manuals, product inserts, and on-product labeling.
• Serve as the SME for global regulatory labeling requirements and branding standards.
• Manage external service providers using Adobe Illustrator and Bartender for label artwork.
• Draft and release engineering change orders within the company's document control system.
• Represent the regulatory labeling function on project teams to assess the impact of design changes.

Requirements

• Work Authorization: Must be a US Citizen or Permanent Resident.
• Bachelor’s degree, preferably in a scientific or engineering field.
• Minimum 5 years of experience in regulatory affairs within the medical device industry.
• Expertise in 21 CFR 800-1299 and US FD&C Section 510(k).
• Experience with EU Medical Device Directive (93/42/EEC) and EU MDR 2017/745.
• Required certification or deep experience with ISO 13485 Quality Management Systems.

Nice to have

• Advanced degree or professional credential in regulatory affairs.
• Experience with e-labeling or content management system applications.
• Proficiency in graphic design or desktop publishing software.
• Hands-on experience maintaining IFUs and capital equipment documentation.

Culture & Benefits

• Comprehensive health and wellness package with full medical coverage.
• Financial security through a 401(k) plan with employer match and equity/RSUs.
• Focus on work-life blend with flexible or paid time off and paid parental leave.
• On-site gym and wellness programs to support employee wellbeing.
• Strong internal growth culture with dedicated management and induction programs.