Regulatory Affairs Specialist II (Medtech)

TL;DR

Regulatory Affairs Specialist II (Medtech): Obtaining and documenting domestic and international regulatory clearances to support the marketing of medical products with an accent on FDA and EU MDR compliance. Focus on drafting 510(k) Premarket Notifications and ensuring technical documentation meets global health authority standards.

Location: Onsite in Irvine, Los Angeles, or Alton, US

Salary: $75,000 - $95,000 per year

Company

hirify.global is a medical technology company specializing in noninvasive patient monitoring and connectivity solutions.

What you will do

• Draft and compile 510(k) Premarket Notifications, Technical Documentation Summaries, and other regulatory submissions.
• Coordinate with regional regulatory team members on product changes and approval requirements.
• Manage communications and responses to inquiries from global health authorities and notified bodies.
• Maintain FDA product listings, establishment registrations, and internal regulatory databases.
• Provide expert regulatory guidance to cross-functional project teams, including Engineering and Marketing.
• Monitor and maintain up-to-date knowledge of international and domestic regulatory requirements.

Requirements

• Bachelor’s degree required (preferably in Engineering, Life Sciences, or Regulatory).
• Minimum 2 years of experience in a medical device Class II/III environment.
• Working knowledge of FDA or international regulations (e.g., EU MDR).
• Experience with ISO 13485 Quality Systems and FDA/GMP requirements.
• Excellent verbal and written communication and documentation skills.
• Must be based in the US to work in an office environment and perform local travel.

Nice to have

• Experience interacting directly with Notified Bodies.
• Successful CE Mark experience for a Class II device.
• Proven track record in successful international and domestic product registrations.

Culture & Benefits

• Comprehensive health package including Medical, Dental, Vision, Life/AD&D, and Disability Insurance.
• Financial incentives such as a 401(k) plan and up to a 10% annual bonus.
• Generous time off including Vacation, Sick, Holiday, and Paid Maternity Leave.
• On-site amenities including a Wellness Clinic, Fitness Center, and Cafe.
• Additional perks like Flexible Spending Accounts and an Employee Assistance Program.