Senior Director, Regulatory Affairs (MedTech & AI/ML)

Synchron; San Diego (CA); Sur place; USD 210 000 - 240 000; Plein temps

Avantages offerts par ce poste

Subsidized medical and dental insurance

401k

Discretionary unlimited PTO

Résumé du poste

Synchron is seeking a Senior Director of Regulatory Affairs for their San Diego office. The ideal candidate will lead regulatory strategies for software, firmware, and hardware in the development of brain-computer interfaces. A minimum of 12 years of regulatory affairs experience in medical devices, particularly Class III, is required.

In this role, you'll partner with cross-functional teams, oversee regulatory submissions, and ensure compliance with FDA regulations. Join Synchron to make a significant impact in the medical device industry.

Qualifications

• 12+ years of regulatory affairs experience in the medical device industry.
• Strong software and firmware regulatory expertise.
• Deep knowledge of 21 CFR Parts 820, 812, 814.

Responsabilités

• Lead regulatory strategy for new BCI platform development.
• Author and manage IDE, PMA, and PMA supplement submissions.
• Ensure compliance with FDA regulations and standards.

Connaissances

Regulatory strategy

Cross-functional leadership

FDA submissions

Problem-solving

Communication skills

Formation

Bachelor’s degree in engineering or life sciences

Advanced degree preferred

Outils

Regulatory compliance tools

Project management software

Description du poste

Synchron is seeking a Senior Director of Regulatory Affairs for their San Diego office. The ideal candidate will lead regulatory strategies for software, firmware, and hardware in the development of brain-computer interfaces. A minimum of 12 years of regulatory affairs experience in medical devices, particularly Class III, is required.

In this role, you'll partner with cross-functional teams, oversee regulatory submissions, and ensure compliance with FDA regulations. Join Synchron to make a significant impact in the medical device industry.