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

As we continue to grow as QuidelOrtho, we are seeking the Regulatory Affairs Specialist performs regulatory activities related to the life cycle management of IVDs (in vitro diagnostics and medical devices) including registrations in the worldwide market, as directed

This position is eligible for remote.

The Position

• Prepares regulatory documentation for domestic (FDA) and international (e.g., EU, etc.) product submissions and registrations.
• Assists in the creation and maintenance of technical files in accordance with applicable standards and regulations.
• Evaluates change control documents for impact on submissions and filing requirements.
• Reviews and approves product labeling and marketing collateral.
• Research regulations and competitor products and create summaries for departmental use.
• Participates on project teams, as qualified, and responsible for providing guidance on regulatory issues and procedural recommendations for standard operating procedures and protocols. 
• Participates in internal auditing and training systems to ensure compliance with quality system.
• Provides support during facilities inspections, licensures and permits, as needed.
• Maintains trackers and reports on status of regulatory activities to RA management.
• Performs other regulatory activities based on level of experience.
• 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 is required; BS/BA in a biological science is preferred.
• Minimum of 3 years’ prior experience in the IVD (in vitro diagnostic), medical device or bio/pharma industry manufacturing environment is required.
• Minimum of 2 years’ prior experience in Regulatory Affairs (or related work experience) is required; an advanced degree may be used to substitute for work experience.
• Strong knowledge of quality systems and good manufacturing practices (GMP) in a manufacturing environment is required.
• Ability to work cohesively …