Cedars-Sinai Regulatory Product Manager - AIM Group in Los Angeles, California
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.
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.