Regulatory Affairs Specialist I (Medical Devices)

Location: Alameda, California, United States; hybrid workplace with on-site work required as needed

Annual base salary: $77,000–$98,000

Company

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

What you will do

• Assist with preparing regulatory submissions, including 510(k), CE Mark Technical Documentation, UKCA, IDE, clinical trial, Shonin, and Certificates to Foreign Government submissions.
• Coordinate and track multiple regulatory projects and maintain submission and approval documentation according to internal procedures.
• Support in-country regulatory affairs personnel with global product clearances and approvals.
• Research regulatory intelligence, including competitor approvals, product information, and updated regulations or guidance.
• Support reviews of Instructions for Use, product labels, and regulatory changes affecting products.
• Train on systems, work instructions, SOPs, and quality-system processes.

Requirements

• Bachelor’s degree in a relevant discipline or an equivalent combination of education and demonstrated experience.
• Ability to apply technical standards, principles, theories, concepts, and techniques.
• Excellent written, oral, and interpersonal communication skills.
• Proficiency with Word, Excel, PowerPoint, and other computer tools.
• Understanding of ISO 13485 quality-system regulations, design control, and regional regulatory requirements.
• Ability and willingness to work on site as needed in Alameda, California; business travel may range from 0% to 30%.

Nice to have

• Regulatory affairs experience in the medical device industry.

Culture & Benefits

• Collaborative environment with continuous learning and performance recognition.
• Medical, dental, vision, life, AD&D, and short- and long-term disability insurance.
• 401(k) with employer match.
• Paid parental leave, eleven company holidays, vacation increasing with tenure, and paid sick time.
• Opportunity to contribute to medical technologies addressing serious diseases.