Regulatory Affairs Manager (SaMD)

We are hiring a Regulatory Affairs Manager (NO prior Management expeirence required) to work hybrid on-site at our location in San Diego, California. This role will be responsible for preparing domestic and international regulatory strategies and submissions for our Software and Imaging technologies; as well as the support of daily activities related to product design teams, change control, and regulatory product submissions.

Responsibilities:

• Collaborates as a core team member on new product development teams. Determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities.
• Provides expertise on domestic and OUS regulatory strategies for products including medical software (SaMD), medical electrical devices, radiation emitting devices, algorithms and artificial intelligence, and cybersecurity.
• Prepares regulatory submissions for new product approvals including 510(k) premarket notifications, EU MDR and ROW.
• Ensures IEC 62304 requirements are applied in the development and improvement of the software lifecycle processes for domestic and OUS submissions.
• Responsible for internal process improvements, data/metric evaluation, maintenance of databases, and public-facing information.
• Evaluates design changes to products to determine impact to submissions and potential need for additional submissions.
• Assists with post-market surveillance evaluation, trending, and reporting, including updates to risk management (FMEA) process.
• Reviews product labeling and promotional materials to ensure consistency with regulatory approvals.
• Researches sources of regulatory information (e.g., regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc.).
• Provides department support during internal and external audits.
• Develops and revises department SOPs/WIs to ensure compliance with applicable global regulatory requirements.
• Maintains FDA establishment listings and registration.
• Other duties as assigned.
  

Background requirements:

• Typically requires a bachelor's degree and 7+ years of experience in the medical device industry including authorship of multiple 510(k)'s.
• Experience with medical imaging/radiation-emitting devices and their clinical usefulness, and software as a medical device (SaMD).
• Knowledge of artificial intelligence and machine learning (AI/ML) enabled medical devices is highly desired
• Strong knowledge of FDA Quality System Requirements (QSR) and ISO 13485.
• Knowledge of EU MDR preferred.
• RAC Certification is preferred.
• Must be detail oriented and have strong technical writing skills.
• Must possess strong interpersonal communication, teamwork and organizational skills.