IVDR Project Manager

Company: Quidel Corporation

Position: IVDR Project Manager

Location: San Diego, California

Posted: August 17, 2020

Quidel Corporation is a leading manufacturer of diagnostic healthcare solutions serving to enhance the health and wellbeing of people around the globe with well-known and respected products that provide healthcare professionals with accurate and cost-effective diagnostic information at the point of care (POC). Our core competencies and capabilities focus on immunoassay and molecular testing in the areas of: infectious disease, cardiology, women’s health, and virology.
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.
ESSENTIAL FUNCTIONS:
  • 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
Knowledge/Skills
  • 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
Before you apply, please make sure you share Quidel’s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be customer drivenfocused on execution, and new product oriented. We succeed by being determinedoptimistic team players.
 
Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.