Senior Director, Regulatory Affairs — BCI Medical Devices

Synchron; San Diego (CA); On-site; USD 210,000 - 240,000; Full time

Benefits offered by this job

Subsidized medical and dental insurance

401(k)

Discretionary unlimited PTO

Flexible Spending Account

Commuter benefits for NY employees

Job summary

Synchron is seeking a Senior Director of Regulatory Affairs for their San Diego operations. This position involves overseeing regulatory strategies for new brain-computer interface (BCI) platform development and managing submissions to regulatory bodies. The ideal candidate will have at least 12 years of experience in regulatory affairs in the medical device sector and a strong background in software and firmware regulations.

This role provides a unique opportunity to influence the development of innovative technologies that aim to improve the quality of life for those with neurological challenges. Selected candidates will enjoy a competitive salary and a comprehensive benefits package.

Qualifications

• 12+ years of regulatory affairs experience in the medical device industry.
• Strong software and firmware regulatory expertise for complex medical devices.
• Track record of leading FDA submissions (IDE, PMA, supplements).

Responsibilities

• Lead regulatory strategy and submission planning for new product development.
• Partner with engineering and clinical teams to integrate regulatory requirements.
• Monitor and ensure compliance with FDA regulations and standards.

Skills

Regulatory affairs experience

Expertise in software and firmware regulations

Leadership in FDA submissions

Knowledge of 21 CFR Parts 820, 812, 814

Communication skills

Education

Bachelor’s degree in engineering, life sciences, or related field

Advanced degree preferred

Job description

Synchron is seeking a Senior Director of Regulatory Affairs for their San Diego operations. This position involves overseeing regulatory strategies for new brain-computer interface (BCI) platform development and managing submissions to regulatory bodies. The ideal candidate will have at least 12 years of experience in regulatory affairs in the medical device sector and a strong background in software and firmware regulations.

This role provides a unique opportunity to influence the development of innovative technologies that aim to improve the quality of life for those with neurological challenges. Selected candidates will enjoy a competitive salary and a comprehensive benefits package.