Sr. Regulatory Affairs Specialist II (Medtech)

TL;DR

Sr. Regulatory Affairs Specialist II (Medtech): Developing and executing worldwide regulatory strategies for medical devices with an accent on EU MDR and USFDA compliance. Focus on leading sustaining engineering projects, managing global submissions, and ensuring compliance for Digital Health and SaMD products.

Location: Hybrid: Must be based in or able to work from Del Mar, CA (in office 2-3 days per week)

Salary: $120,000 - $135,000

Company

hirify.global is a leader in diabetes technology, specializing in advanced insulin pump systems like Tandem Mobi and t:slim X2.

What you will do

• Develop worldwide regulatory strategies for new product launches and the maintenance of existing products.
• Serve as the regulatory lead for sustaining engineering projects, assessing the impact of design changes in EU, UK, and other global markets.
• Prepare and negotiate global regulatory submissions, including 510(k), De Novo, and CE Mark Technical Files.
• Provide expert guidance on Digital Health and Software as a Medical Device (SaMD) regulations.
• Review promotional materials to ensure compliance with US and international regulations.
• Act as the company representative during regulatory inspections.

Requirements

• Bachelor's degree in Science, Regulatory Affairs, Engineering, or Mathematics.
• 7+ years of experience in regulatory functions within the medical device or health IT industry.
• Proven experience supporting Class III devices per Regulation (EU) 2017/745 (MDR).
• Proficiency in ISO 13485, 21CFR Part 820, and GMP standards.
• Demonstrated experience communicating with regulatory agencies including FDA, Health Canada, and EU agencies.
• Must be authorized to work in the U.S. (No sponsorship available).

Nice to have

• Regulatory Affairs Certification (RAC).
• Knowledge of IEC 62304 and the software life cycle.

Culture & Benefits

• Comprehensive health, dental, and vision insurance available on the first day.
• Health Savings Accounts (HSA) and Flexible Saving Accounts (FSA).
• 401k plan with company match and Employee Stock Purchase plan.
• Minimum of 20 days PTO plus 11 paid holidays per year.
• Work environment that celebrates achievements and supports well-being.