Senior Regulatory Affairs Specialist

The Opportunity

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.

The Role

At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next The Senior Regulatory Affairs Specialist. This role manages regulatory activities related to the development and approval of new in vitro diagnostics and medical devices into the worldwide market, as directed.  Reviews and approves U.S. and IVDR regulatory submissions. 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. Promotes awareness of applicable regulatory and customer requirements to cross functional partners during new product development and life cycle management projects.

This role is remote eligible for candidates based on the West Coast of the United States.

The Responsibilities

• Manages new product development and U.S. submissions activities for a set of medical devices and/or IVD products.

• Works as primary core team member on new point of care and molecular product development teams and establishes regulatory strategy to achieve market clearance. 

• Prepares, reviews and approves U.S. (FDA) and/or global product submissions; reviews and approves other regulatory documentation generated during the new product development effort to support international product submissions and registrations.

• IVDR submission and gap assessments experience

• Supervises interactions with government agencies for regulatory submissions.

• Reviews and approves Marketing/Sales literature and labeling.

• Establishes and/or owns regulatory affairs processes and acts as subject matter expert during inspections.

• Worked on Corporate initiatives for organizational improvements, such as standards management.

• Works with RIMS system and is proficient in data gathering and maintenance of a RIMS system. 

• Develops and presents training materials for regulatory requirements and/or department processes.

• Evaluates change control documents for impact on regulatory submissions and filing requirements, as needed.

• Research regulations and competitor products and create summaries for departmental use.

• Implements, manages, and continuously improves related regulatory processes, tools, and trackers

• Ensure regulatory records are complete and well organized.

• Carries out duties in compliance with established business policies.

• Perform other work-related duties as assigned

The Individual

Required:

• Bachelor’s degree (BS/BA) in a scientific discipline

• Minimum of 4 years prior experience in the IVD (in vitro diagnostic), medical device or bio/pharma industry