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Regulatory Affairs Manager (SaMD)
- Posted 18 May 2023
- Salary US$140000 - US$155000.00 per annum + bonus, benefits, hybrid work
- Job type Permanent
- DisciplineLife Sciences
- Contact NameMelody Lam
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.
- 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.
- 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.