Regulatory Affairs Associate

QuidelOrtho Corporation; United Kingdom; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading diagnostics company is hiring a Regulatory Affairs Associate in Pencoed. This role involves supporting regulatory operations in the Transfusion Medicine unit, providing assistance with submission requirements, and working with global teams. A bachelor’s degree in a scientific field and experience in regulated industries is required. Competitive salary and benefits are offered.

Benefits

Competitive Salary

Yearly Salary Reviews

Attractive Pension Scheme

Bonus Scheme

Life Assurance

Private Medical

LinkedIn Learning

Cycle to Work Scheme

Free Onsite Gym

Subsidised Canteen

25 days Holidays + 1 QuidelOrtho Day + 8 Bank Holidays

Employee Assistance Programme

Reward & Recognition Programmes

State-Of-The-Art facilities

Exceptional career development prospects

Strong culture centered around collaboration & customer focus

Qualifications

• Experience in FDA and/or EU regulated industries required.
• Experience with submission of regulatory applications (510(k), BLA, EU Notified Body).
• Ability to manage multiple tasks/projects/priorities.

Responsibilities

• Support regulatory affairs operations in Transfusion Medicine.
• Provide regulatory support for project teams regarding submissions.
• Interact with international regulatory personnel.

Skills

Excellent interpersonal skills

Teamwork

Verbal communication

Written communication

Organizational skills

Regulatory strategy support

Education

Bachelor’s degree in a Scientific field

Job description

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a worldwide 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.

Regulatory Affairs Associate

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

Your New Role

As a 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.

What You’ll Be Doing

• Provide regulatory support to Transfusion Medicine project teams in terms of submission requirements, timing, and risks.
• Interact with International regulatory personnel to define submission content, monitor pending applications and support the resolution of regulatory matters.
• Support base business activities, such as International Change Notifications / Annual Reports, and change management reviews for regulatory submission impact.
• Support the preparation of submissions to meet regulatory agency expectations.
• Independently make decisions regarding work processes or operational plans in order to achieve department objectives.
• Identify and/or support process improvement projects to streamline current activities and increase department efficiencies.
• Provide support 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 submission of 510(k) and/or BLA applications or EU Notified Body applications for IVD products or biological drug products.

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.