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- Tasks: Support regulatory affairs in transfusion medicine and manage submissions to health authorities.
- Company: Join QuidelOrtho, a leading diagnostics company with a focus on employee happiness.
- Benefits: Competitive salary, yearly reviews, attractive pension, private medical, and more.
- Why this job: Make a real impact in healthcare while developing your career in a supportive environment.
- Qualifications: Bachelor’s degree in a scientific field or relevant regulatory experience required.
- Other info: Dynamic team culture with exceptional career growth opportunities.
The predicted salary is between 36000 - 60000 £ per year.
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.
We are hiring for a Senior Regulatory Affairs Associate to join our team based in Pencoed on a 24 month fixed‑term contract basis. 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.
Senior Regulatory Affairs Associate employer: Ortho Clinical Diagnostics
Contact Detail:
Ortho Clinical Diagnostics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Associate
✨Tip Number 1
Network like a pro! Reach out to current employees at QuidelOrtho on LinkedIn or through industry events. A friendly chat can give you insider info and maybe even a referral!
✨Tip Number 2
Prepare for the interview by researching QuidelOrtho's recent projects and achievements. Show us that you're genuinely interested in our mission and how your skills can contribute to our goals.
✨Tip Number 3
Practice common interview questions, especially those related to regulatory affairs. We want to see how you handle real-world scenarios, so think of examples from your past experiences.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows us you’re serious about joining our team.
We think you need these skills to ace Senior Regulatory Affairs Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Associate role. Highlight your relevant experience in regulatory affairs, especially with FDA and EU regulations. We want to see how your background aligns with our mission at QuidelOrtho!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how you can contribute to our team. Don’t forget to mention any specific projects or experiences that relate to transfusion medicine.
Showcase Your Communication Skills: Since this role requires excellent verbal and written communication skills, make sure your application reflects that. Use clear and concise language, and don’t hesitate to demonstrate your ability to interact with regulatory personnel effectively.
Apply Through Our Website: We encourage you to apply through our website for the best chance of being noticed. It’s the easiest way for us to keep track of your application and ensure it gets to the right people. Plus, we love seeing candidates who take the initiative!
How to prepare for a job interview at Ortho Clinical Diagnostics
✨Know Your Regulatory Stuff
Make sure you brush up on the latest FDA and EU regulations, especially those related to in vitro diagnostics. Being able to discuss specific submission processes or recent changes in regulations will show that you're not just familiar with the basics but are genuinely engaged with the field.
✨Showcase Your Teamwork Skills
Since this role involves working with various project teams, be ready to share examples of how you've successfully collaborated in the past. Highlight your interpersonal skills and how you've navigated challenges with team members across different time zones.
✨Prepare for Scenario Questions
Expect questions that ask how you'd handle specific regulatory challenges or project timelines. Think about past experiences where you had to make quick decisions or manage multiple priorities, and be prepared to explain your thought process.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions that show your interest in the company culture and the role. Inquire about how the team approaches regulatory changes or what process improvement projects they have in mind. This shows you're thinking ahead and are keen to contribute.