Sr Regulatory Affairs Specialist (Medical Devices)

Location: Onsite in Irvine, California, United States. The position primarily works in an office environment and requires some local travel with a valid driver's license.

Salary: $85,000–$130,000 per year, plus benefits and eligibility for up to a 10% annual performance bonus.

Company

Medical device operations focused on domestic and international regulatory clearances, registrations, and compliance.

What you will do

• Own regulatory objectives for domestic and international product and country registrations.
• Draft and compile 510(k) premarket notifications and other regulatory submissions.
• Manage filings, registrations, product listings, and FDA establishment registrations.
• Maintain technical documentation summaries, regulatory databases, quality system procedures, and regulatory reports.
• Coordinate with regional regulatory teams, health authorities, and notified bodies on filings, responses, and product changes.
• Lead QA and Engineering initiatives, provide regulatory guidance in project meetings, and train colleagues on applicable requirements.

Requirements

• At least 3 years of experience in a Class II/III medical device environment.
• Expert understanding of FDA or international medical device regulations, including FDA/GMP requirements.
• Experience with ISO 13485 quality systems and FDA Class II submission requirements.
• Bachelor's degree required, preferably in Engineering, Life Sciences, or Regulatory Affairs.
• Experience with regulatory documentation, traceability, record maintenance, prioritization, and cross-functional project work.
• Excellent verbal and written communication skills and the ability to work independently with minimal supervision.

Nice to have

• Experience with patient monitoring systems, hospital-based products, software, or electronic devices.
• Experience leading regulatory interpretations during product development.
• Successful CE Marking of a Class II device.
• Experience authoring and obtaining 510(k) clearance.
• Experience with international and domestic product registrations.

Culture & Benefits

• Collaboration with Sales, Marketing, QA, Engineering, and regional regulatory teams.
• Medical, dental, vision, life, disability, and employee assistance benefits.
• 401(k), vacation, sick leave, holidays, paid maternity leave, and flexible spending accounts.
• Additional voluntary insurance options, pet insurance, onsite wellness clinic, fitness center, and café.