San Diego, CA
IVDR Project Manager
General Job Description:
The IVDR Project Manager has a company-wide scope and is designed to lead the implementation of projects and conversion of processes related to the In Vitro Diagnostics Regulation (IVDR). This role functions interchangeably as a participant or as a leader on teams responsible for changing SOP’s, Technical Files, contacts, training and issues related to the IVDR. Evaluates changes in terms of documentation and compliance with the IVDR. Assesses and communicates impact on EU submissions and filing requirements. Provides regulatory affairs assessment for change control documents to ensure compliance to regulations and provides regulatory opinion for complex or unique issues regarding the IVDR. Supports QA during inspections and audits related to the IVDR.
Your Contributions (include, but are not limited to):
Identifies issues to be addressed and areas of concern where IVDR may hinder the registration and sale of Quidel products
Prepares and communicates IVDR project-related documentation and budgets
Leads teams that are necessary to complete required changes including: SOP’s, training, systems support and development, labeling, processes for product launch in the EU, supports efforts to manage Economic Operators and other duties
Participates in internal auditing and training systems to ensure compliance with the quality system
Monitors and interprets IVDR regulations and guidelines and interacts with project teams to provide guidance to complete deliverables per established deadlines
Works closely with QA on all matters to assure consistency and alignment between QA and Regulatory departments
Participates in the development, review or approval of labeling, Marketing / Sales literature, or SOPs and protocol changes in clinical trials.
Reviews and/or audits data related to regulatory projects and functions.
Carries out duties in compliance with established business policies
Education and experience:
Requires a bachelor’s degree (BS/BA) in a biological science with a minimum of 5 - 8 years experience in a pharmaceutical, medical device or IVD manufacturing environment
Current knowledge and experience with IVDR and / or the MDR is required
Must have experience in the preparation and submission of regulatory documentation including international registrations
Direct interactions with FDA and other regulatory agencies preferred
Strong knowledge of quality systems in a manufacturing environment
Working knowledge of current FDA, IVDD and especially IVDR regulations
Ability to work cohesively with multi-disciplinary scientific working groups
Excellent written, verbal and interpersonal skills to influence many diverse internal/external customer groups
Must be able to lead, manage and communicate action items and results from and in meetings in a logical fashion.
Project management experience is required including proficiency with project tools such as GANTT and PERT charts, MS Project and other tools
Application Information & Contact (How to Apply)
Please apply through the Quidel job portal
Learn more about Quidel here.