Regulatory Affairs Director — Medical Devices

Surf Search; Carlsbad (CA); Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Surf Search is seeking a hands-on Director of Regulatory Affairs to lead regulatory strategy and execution for new medical device development and commercialization. This role drives premarket submissions, secures product approvals, and ensures ongoing compliance with global regulatory requirements.

The ideal candidate will bring extensive regulatory expertise for Class II and III devices, mentor a growing regulatory team, and partner with R&D, Quality, Clinical, and Commercial teams throughout

Formación

• Bachelor's degree in engineering, life sciences, or related technical field.
• 5+ years of regulatory affairs experience in medical devices.
• Experience with premarket submissions (510(k), PMA) and approvals.
• Strong knowledge of FDA regulations, 21 CFR, ISO standards, and EU MDR.
• Experience mentoring/regulatory teams and leading projects.

Responsabilidades

• Develop and implement regulatory strategies for new product development, commercialization, and global expansion.
• Lead preparation, review, and submission of regulatory applications (FDA 510(k), PMA, international).
• Manage regulatory approval pathways and registrations for US and international markets.
• Provide regulatory guidance across the product lifecycle with R&D, QC, Clinical, and Commercial teams.
• Ensure compliance with FDA, ISO, and EU MDR and respond to inquiries from authorities.
• Oversee regulatory documentation, technical files, and submission records.
• Participate in product risk management and provide regulatory input to design decisions.
• Manage regulatory project timelines, priorities, and launches.
• Coordinate with external regulatory consultants and partners as needed.

Conocimientos

Regulatory affairs

FDA regulations

21 CFR

EU MDR

510(k) submissions

PMA submissions

Leadership

Mentoring

Project management

Global compliance

Educación

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

Descripción del empleo

Surf Search is seeking a hands-on Director of Regulatory Affairs to lead regulatory strategy and execution for new medical device development and commercialization. This role drives premarket submissions, secures product approvals, and ensures ongoing compliance with global regulatory requirements.

The ideal candidate will bring extensive regulatory expertise for Class II and III devices, mentor a growing regulatory team, and partner with R&D, Quality, Clinical, and Commercial teams throughout