The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Cedars-Sinai Medical Center's AIM Group is currently seeking a full-time Regulatory Product Manager to join our team. In this dynamic position, you will serve as the regulatory product manager providing expertise for engineering, manufacturing, and product teams throughout the entire design control process. The role will provide regulatory expertise during design input & output creation, verification, validation, full quality assurance testing. The role will review design documentation to meet regulatory compliance throughout the full life cycle of the device, including defect and complaint reviews, and post market usability surveys. The role will provide guidance to the team on risk assessment and required corrective actions to meet regulatory requirements.
Please apply through Cedars-Sinai website: https://jobs.cedars-sinai.edu/job/los-angeles/regulatory-product-manager-aim-group/252/9963154864
RAC certification preferred
Minimum five (5) years’ experience, of which at least one (1) year in the regulatory environment of the Software Medical Device industry.
Experience with successful preparations and submissions packages for domestic and international market clearance and registration purposes.
Internal Number: HRC0523178A
Cedars-Sinai is a nonprofit, independent healthcare organization committed to improving the health status of the communities we serve through:
- Leadership and excellence in delivering quality healthcare services
- Expanding the horizons of medical knowledge through biomedical research
- Educating and training physicians and other healthcare professionals
- Improving the health status of the community