We have an exciting opportunity for a 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.
Essential Duties and 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.
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Typically requires a bachelor's degree and 3-5 years of experience in the medical device industry.
- 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.
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).
We are committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, we will make reasonable accommodations that are necessary to comply with disability discrimination laws.
Our company complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $110,000 to $145,000 Full-Time Annual Salary