Sr. Regulatory Affairs Specialist II (Medtech)

TL;DR

Sr. Regulatory Affairs Specialist II (Medtech): Developing global regulatory strategies and managing submissions for innovative diabetes technology products with an accent on Class III medical devices and Software as a Medical Device (SaMD). Focus on ensuring compliance with USFDA, EU MDR, and ISO 13485 standards while driving continuous improvement in regulatory processes.

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

Salary: $120,000 – $135,000

Company

A leader in the diabetes technology industry dedicated to creating innovative insulin delivery systems through a human-centered design approach.

What you will do

• Develop and execute global regulatory strategies for new product introductions and sustaining engineering projects.
• Prepare and negotiate worldwide regulatory submissions, including 510(k), De Novo, and CE Mark technical files.
• Serve as the regulatory lead on cross-functional product design and development teams.
• Interpret and apply global medical device regulations, specifically focusing on Digital Health and SaMD.
• Review promotional materials and ensure compliance with international regulations and company policies.
• Represent the company during regulatory inspections and liaise with health authorities globally.

Requirements

• Must be authorized to work in the U.S. (No sponsorship available)
• Bachelor’s degree in Science, Regulatory Affairs, Technology, Engineering, or Mathematics.
• 7+ years of experience in a regulatory function within the medical device or health IT industry.
• Demonstrated experience with Class III devices and Regulation (EU) 2017/745.
• Proficiency in quality standards including ISO 13485, 21CFR Part 820, and GMP.
• Significant experience with software-containing products and IEC 62304 standards.

Nice to have

• Regulatory Affairs Certificate (RAC) from RAPS.
• Documented past training in medical device regulations.

Culture & Benefits

• Comprehensive health care benefits (medical, dental, vision) effective from day one.
• 401(k) plan with company match and Employee Stock Purchase plan.
• Generous time off policy including 11 paid holidays and 20+ days of PTO.
• Supportive, inclusive workplace culture focused on innovation and employee well-being.
• Opportunities for professional growth within a mission-driven team.