Director, Global Regulatory Affairs - Medical Devices

Surf Search; Carlsbad (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

Surf Search Inc. seeks a hands-on Director of Regulatory Affairs to guide regulatory strategy and execution for medical device development and commercialization in the United States.

The role centers on premarket submissions, product approvals, and ongoing global regulatory compliance. The ideal candidate will mentor a growing regulatory team and lead FDA submissions (510(k), PMA) with international experience, collaborating closely with R&D, Quality, Clinical, and Commercial teams to drive

Qualifications

• Bachelor-level engineering, life sciences, or related technical discipline.
• Minimum of 5 years in regulatory affairs within medical devices.
• Experience preparing premarket submissions and obtaining approvals.
• Strong knowledge of FDA regulations, 21 CFR, ISO standards, and EU MDR.

Responsibilities

• Develop and execute regulatory strategies for new product development and global expansion.
• Lead preparation, review, and submission of regulatory applications (FDA 510(k), PMA, international submissions).
• Manage regulatory approval pathways and registrations for US and international markets.
• Provide regulatory guidance across product lifecycle, partnering with R&D, Quality, Clinical, and Commercial teams.
• Ensure compliance with FDA, ISO, and international regulatory requirements, including EU MDR.
• Serve as main contact for regulatory authorities and manage inquiries.

Skills

Regulatory affairs leadership

FDA/regulatory submissions

Project management

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Job description

Surf Search Inc. seeks a hands-on Director of Regulatory Affairs to guide regulatory strategy and execution for medical device development and commercialization in the United States.

The role centers on premarket submissions, product approvals, and ongoing global regulatory compliance. The ideal candidate will mentor a growing regulatory team and lead FDA submissions (510(k), PMA) with international experience, collaborating closely with R&D, Quality, Clinical, and Commercial teams to drive