Senior Regulatory Affairs Associate

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.

Senior Regulatory Affairs Associate

We are hiring for a Senior Regulatory Affairs Associate to join our team based in Pencoed on a 24 month fixed-term contract basis.

About QuidelOrtho, Pencoed

QuidelOrtho has been manufacturing products in South Wales for over 40 years. Our state-of-the-art manufacturing facility, based in Pencoed, employs over 600 people who are involved in the manufacture and supply of clinical laboratory and immunohematology products to sites across the globe.

Our Pencoed team manufacture a large menu of immunohematology products used in transfusion medicine; in addition to a large menu of immunoassay products encompassing a range of disease categories.

On site we have a range of functions operating globally & locally. All our employees are working towards one common goal, to help save and improve lives through diagnostics.

Your New Role:
As a Senior Regulatory Affairs Associate your primary responsibility will be to support the day-to-day regulatory affairs base business operations within the Transfusion Medicine Business Unit.
You will, with minimal oversight, manage and oversee the coordination, compilation and submission of regulatory applications to health authorities.

What you’ll be doing:

• Provide regulatory support to Transfusion Medicine project teams in terms of submission requirements, timing, and risks.
• Interact with US FDA and/ or International regulatory personnel to define submission content, expedite pending applications, and resolve regulatory matters.
• Support base business activities, such as Notified Body Change Notifications / International Change Notifications / Annual Reports / CBE-30 & PAS submissions, Labelling reviews, and change management reviews for regulatory submission impact.
• Prepare submissions to meet regulatory agency expectations.
• Independently make decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
• Identify and/ or support process improvement projects to streamline current activities and increase department efficiencies.
• Provide guidance to business partners regarding regulatory requirements including indications of risk and approximate timing for approvals for planning purposes.
• Perform other work related duties as assigned.

What you’ll need to succeed:

• Bachelor’s degree in a Scientific or related field, or previous relevant experience within a regulatory/quality based role.
• Experience in an FDA and or EU (IVDR) Regulated Medical Device or Pharmaceuticals Industry required, Biologics Industry experience preferred
• Excellent interpersonal, teamwork and verbal/written communication skills are required.
• Good organizational skills and an ability to manage multiple tasks/projects/priorities.
• The ability to work with business partners across geographies and time zones is critical.
• Experience supporting Regulatory strategies and product development programs.
• Experience should consist of either direct submission of 510(k) and/or BLA applications or EU Notified Body applications for IVD products or biological drug products.
• Experience with Combination product regulations is desired.

What we offer:

• Competitive Salary
• Yearly Salary Reviews
• Attractive Pension Scheme
• Bonus Scheme
• Life Assurance
• Private Medical (If applicable)
• LinkedIn Learning
• Cycle to Work Scheme
• Free Onsite Gym
• Subsidised Canteen
• 25 days Holidays + 1 QuidelOrtho Day + 8 Bank Holidays (Milestone Increases Available)
• Employee Assistance Programme
• Reward & Recognition Programmes
• State-Of-The-Art facilities
• Exceptional career developmental prospects
• Strong culture centred around collaboration & customer focus.

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