Senior Manager, Regulatory Affairs

1w1 week ago

QuidelOrtho

US · Full-time · $155,677 – $202,380

About this role

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with expertise in immunoassay, molecular testing, clinical chemistry, and transfusion medicine. The company employs more than 6,000 people and operates in over 130 countries, delivering fast, accurate testing from home to hospital.

Join as Senior Manager of Regulatory Affairs to manage and support a team of managers and employees. Develop and implement local strategy while leading day-to-day regulatory affairs for base business operations and new product development in the Transfusion Medicine Business Unit. This position is remote eligible with preference for certain locations.

Review regulations and interact with US FDA and EU Notified Body personnel to define submission content and resolve matters. Make judgments on operational impacts and represent QuidelOrtho to regulatory agencies. Final review critical regulatory documents for submissions and responses.

Our culture puts team members first, prioritizing actions that support happiness, inspiration, and engagement. Build meaningful connections as employee happiness links to business success. Advance the power of diagnostics for a healthier future for all.

Requirements

Experience developing regulatory strategies for transfusion medicine or in vitro diagnostics products
Knowledge of US FDA submission pathways, including 510(k), PMA, and clinical requirements
Familiarity with EU Notified Body interactions and IVDR requirements
Ability to interpret regulations and guidance for predicate device selection and risk assessment
Leadership skills to manage regulatory affairs teams
Expertise in resolving regulatory matters with agencies and health ministries
Proficiency in reviewing critical regulatory submission documents

Responsibilities

Develop regulatory strategy to support Transfusion Medicine project teams by reviewing and interpreting regulations and guidance documents, including submission pathway, clinical efficacy requirements, predicate device selection, timing, and risks
Interact with US FDA and EU Notified Body regulatory personnel to define submission content, expedite pending applications, resolve regulatory matters, and conduct final review of critical regulatory documents
Make judgments about the operational impact of proposed actions and interact with resources to achieve company and regulatory strategy objectives
Review and interpret product-specific regulatory issues with material impact on the business, corporation, or customer, and develop strategic and tactical responses
Represent QuidelOrtho to US and EU regulatory agencies and interact with Health ministry personnel to expedite pending applications, resolve regulatory matters, and manage development meetings
Manage and support a team of managers and employees of different levels
Lead day-to-day regulatory affairs on base business operations and new product development projects within the Transfusion Medicine Business Unit