Senior Manager Regulatory Affairs

QuidelOrtho

6d•Remote

About The Position

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Manager of Regulatory Affairs. The role manages regulatory activities related to the life cycle management of IVDs (in vitro diagnostics) and medical devices, including approval of products in the worldwide market, as directed. Responsible for IVDR submissions and compliance to the standard. Leads a group of RA staff who provide routine post-market support, participate on project teams, and provide guidance and strategies for regulatory issues. Reviews and approves UE Technical Documentation Files. Interacts with regulatory agencies regarding product registrations, licensures, and permits and supports regulatory compliance to QSR, ISO, CMDR, MDSAP, IVDD/IVDR, CFR and other worldwide regulatory requirements. Reviews and approves labeling and Marketing/Sales literature. This position is remote eligible, with a strong preference for candidates who reside in San Diego, CA, Rochester, NY, Pompano, FL or Raritan, NJ.

Requirements

Bachelor's degree (BS/BA) in a scientific discipline.
10 years' prior experience in the IVD (in vitro diagnostic), medical device or bio/pharma industry.
10 years' prior regulatory affairs experience (or related educational/work experience) with progression of responsibility and leadership.
Prior experience in the preparation and submission of regulatory documentation including, but not limited to, 510(k) submissions, international registrations, and/or EU technical documentation files.
Prior experience as a project team member.
Prior direct interaction with FDA or other regulatory agencies.
Advanced knowledge of quality systems and GMP.
Advanced knowledge of current and evolving regulations for medical device (IVD) approval.
Demonstrated ability to understand and make decisions for complex situations.
Demonstrated leadership skills.
Ability to work cohesively with multi-disciplinary scientific working groups.
Excellent written and verbal interpersonal skills to influence many diverse internal/external customer groups.
Must possess a high degree of accuracy and attention to detail.
Ability to support Clinical, R&D, V&V, and PMO departments on an as needed basis in order to meet corporate objectives.
Ability to work independently and be self-motivated.
Ability to work under minimal supervision following established procedures.
Ability to handle inter/intradepartmental issues in a cooperative and diplomatic manner is required.
Ability to work on assignments of high visibility where independent action and a high degree of initiative is needed in resolving problems and developing recommendations.
Ability to work on multiple projects simultaneously.
Ability to exercise judgment within defined procedures and practices to determine appropriate action.
Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Visio.
This position is not currently eligible for visa sponsorship.

Nice To Haves

5 years in IVD/ Medical Device industry working for a device manufacturer
Prior direct management and/or mentorship of staff
5 years leadership experience

Responsibilities

Leads and manages a group of RA staff who support post-market activities for a designated set of medical device and/or IVD products.
Prepares regulatory documentation to support domestic and international product submissions and registrations.
Liaises with in-country regulatory partners and government agencies for regulatory submissions.
Evaluates change control documents for impact on regulatory submissions and filing requirements.
Implements, manages, and continuously improves related regulatory processes, tools, and trackers.
Reviews and approves verification and validation protocols and reports.
Reviews and approves Marketing/Sales literature and product labeling.
Manages Enterprise system entries for global trade compliance and legal distribution of product.
Establishes and/or owns regulatory affairs processes and acts as subject matter expert during inspections.
Ensures regulatory records are complete and well organized.
Develops and presents training materials for regulatory requirements and/or department processes.
Carries out duties in compliance with established business policies.
Perform other work-related duties as assigned.