Senior Regulatory Affairs Specialist

TL;DR

Senior Regulatory Affairs Specialist (Medical Robotics): Develop global regulatory strategies for new and modified Class II and III devices for urological surgery with an accent on FDA submissions, EU MDR compliance, and international standards. Focus on leading regulatory representation on product teams, monitoring regulations, problem-solving compliance issues, and ensuring QMS execution.

Hybrid in San Jose, CA. For US-Based Candidates Only. Work Authorization Status: Citizen / Permanent Resident.

$145,000 - $170,000 a year

Company

hirify.global revolutionizes treatment for benign prostatic hyperplasia through innovation in surgical robotics.

What you will do

• Act as lead regulatory representative on product development teams, communicating requirements and providing input on FDA and international registrations.
• Develop global regulatory strategies for new and modified products.
• Monitor and interpret current and new regulatory requirements and standards for US and RoW.
• Support compliance with FDA regulations and EU-MDR, identify and solve issues.
• Drive process improvements, mentor regulatory talent, and ensure QMSR compliance.
• Execute US FDA 510(k) and Technical File creation and remediation.

Requirements

• Bachelor’s Degree in scientific discipline (Chemistry, Life Sciences, Biology or equivalent).
• 6 years’ experience with B.S. or 4 years with M.S. in regulatory submissions for medical devices.
• Experience with 21 CFR 820, ISO 13485, Medical Devices Directive (93/42/EEC) and/or IVD Directive.
• Ability to work on project teams and manage multiple priorities with minimal oversight.
• Must be US-based Citizen or Permanent Resident.

Nice to have

• M.S. or Ph.D. in technical area.
• Experience with Class II and III medical devices.
• RAC certification.
• Strong knowledge of US, EU MDR, and international regulatory requirements.

Culture & Benefits

• Comprehensive health coverage, wellness programs, on-site gym.
• 401(k) with employer match, short/long-term disability, life insurance.
• Flexible/PTO, paid parental leave, paid holidays.
• Induction program, management training, focus on work/life blend.
• Emphasis on innovation, team building, and career growth.