Manager, Quality & Regulatory Compliance (Medical Devices)

Location: USA - CA, Goleta. Applicants must be currently authorized to work in the United States without visa sponsorship.

Salary: $140,000–$150,000 base salary per year, plus performance bonus and benefits.

Company

hirify.global provides virtual healthcare solutions and works to expand access to care.

What you will do

• Maintain and improve the Quality Management System in compliance with ISO 13485 and applicable regulations.
• Manage document control, SOPs, training, quality records, management reviews, and internal, external, and certification audits.
• Lead CAPA processes, root-cause investigations, corrective actions, nonconformance investigations, and continuous improvement initiatives.
• Manage supplier qualification, audits, approved supplier activities, performance monitoring, and supplier change assessments.
• Oversee complaint investigations, adverse event reporting, trending, post-market surveillance, and quality signal escalation.
• Support product risk management, design controls, product development, verification, validation, change management, regulatory submissions, product registrations, approvals, licenses, CE Marking, and compliant labeling and promotional claims.

Requirements

• Bachelor's degree in Engineering, Quality, Regulatory Affairs, Life Sciences, or a related field.
• 7+ years of experience in medical devices, healthcare technology, or another regulated industry.
• Experience with ISO 13485 or a similar quality management system.
• Knowledge of CAPA, audits, supplier quality, complaint handling, risk management, and design controls.
• Strong project management, organizational, and communication skills.
• Current authorization to work in the United States without visa sponsorship now or in the future is required.

Nice to have

• ASQ certification.
• Lead Auditor certification.
• Experience supporting regulatory inspections and certification audits.

Culture & Benefits

• Flexible Vacation Policy, subject to manager approval.
• 80 hours of Paid Sick, Safe, and Caregiver Leave annually for eligible full-time employees.
• Performance bonus and benefits subject to eligibility requirements.
• Opportunities for professional growth and career development.
• Inclusive workplace and benefits programs for employees and families.

Hiring process

• Identity and credential verification.
• Live or video interviews.
• Fraud and misrepresentation screening.