Regulatory Affairs Specialist / Senior Specialist

We are hiring a Regulatory Affairs Specialist OR Senior Regulatory Affairs Specialist to work on-site at our location in San Diego, California. This role will be responsible for preparing domestic and international regulatory strategies and submissions 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.
• 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.

Requirements

• Bachelor's degree and 3-5 years of experience in the medical device industry and specifically with Spinal products.
• Hands-on authorship or co-authorship of 510(k) submissions is required.
• 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.