Regulatory Affairs Specialist II (Medical Devices)

Location: Alameda, California, United States; hybrid workplace with willingness and ability to work on site required. Business travel may be required for 10%–30% of the time.

Annual base salary: $90,000–$125,000.

Company

hirify.global is a healthcare product company that designs, develops, manufactures, and markets innovative medical technologies for challenging medical conditions.

What you will do

• Prepare moderately complex regulatory submissions for clinical research, export, and commercial distribution, including IDE, 510(k), CE Mark Technical Dossier, UKCA Mark, and regional submissions.
• Coordinate multiple projects and maintain existing approvals and regulatory documentation.
• Communicate with in-country regulatory affairs personnel and regulatory agencies to facilitate global clearances and approvals.
• Research FDA clearances and approvals of competitors and share relevant findings with internal stakeholders.
• Review design control documents, quality system procedures, labeling, promotional materials, and risk management documentation for regulatory compliance.
• Support strategic research, corrective actions, and improvements to work instructions, SOPs, and quality system procedures.

Requirements

• Bachelor's degree in a science discipline or related field with 2+ years of experience, or an equivalent combination of education and experience.
• Experience in medical device regulatory affairs is preferred.
• Knowledge of quality systems, biocompatibility, design control, medical device regulations, ISO 13485, labeling, export requirements, and regional regulatory requirements.
• Strong technical, written, oral, and interpersonal communication skills with high attention to detail.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Ability to prioritize assignments and manage multiple projects concurrently.

Culture & Benefits

• Collaborative environment with continuous learning and performance recognition.
• Medical, dental, vision, life, AD&D, short-term disability, and long-term disability insurance for eligible employees.
• 401(k) with employer match, paid parental leave, paid sick time, and at least fifteen accrued vacation days per year.
• Eleven paid company holidays annually, with vacation increasing based on tenure.
• General office and laboratory work involving extended computer use, movement between buildings and floors, and potential exposure to blood-borne pathogens.