IVDR Project Manager
Company: Quidel Corporation
Position: IVDR Project Manager
Location: San Diego, California
Posted: August 17, 2020
- 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
- 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