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.
Essential job duties and responsibilities:
Develop and implement a domestic and international regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and AIM products.
Responsible for the planning, coordination, preparation, and completion of document packages for regulatory submissions to the US, EU, Canada, Japan, Australia, etc... (e.g. pre-submissions, 510(k)s, EU MDD/MDR and MDSAP documentation, Technical and clinical file documentation, etc...).
Defend audits from regulatory and quality standard agencies such as FDA, EU (CE-Mark), ISO MDSAP and private distributors that require a quality and regulatory based milestone.
Take full ownership of existing QMS based on FDA QSR and the harmonized standards ISO 13485:2016, ISO 15233-1:2016, IEC 62304:2006/AMD 1:2015, IEC 62366-1:2015, EN 1041:2008+A1:2013, EN ISO 14971:2012, EU MDD/MDR and MDSAP.
Authors and conducts internal audits to ensure compliance with procedures.
Assists with negotiations with private distributors as it relates to quality and regulatory requirements.
Keeps abreast of, interpret, and communicate applicable regulatory agency regulations and statutes with internal departments and ensure full timely compliance.
Develops regulatory strategies for the introduction of new and/or modified software products.
Serve as the regulatory expert for engineering, manufacturing, and product teams throughout the design control process; offering regulatory expertise during design input & output creation, verification, validation, full QA testing, including review of design documentation to meet regulatory compliance throughout the full life cycle of the device, including defect and complaint reviews, post market usability surveys, provide guidance to the team on risk assessment and required corrective actions to meet regulatory requirements.
Bachelor's Degree in an appropriate scientific or other related field is required
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.
Working Title: Regulatory Product Manager - AIM Group
Department: Intellectual Prop Cardiac Imag
Business Entity: Corporate Services
City: Los Angeles
Job Category: Corporate Services, Family & Function
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.