Regulatory Affairs Manager, - In Vitro Diagnostic (IVD) Medical Devices - Various locations (EU)

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Regulatory Affairs Manager - In Vitro Diagnostic (IVD) Medical Devices

The role:

As a Regulatory Affairs Manager you will need to be experienced with In Vitro Diagnostic (IVD) Medical Device and CDx directives, regulation, and regulatory structure (required Economic Operator and Personnel roles, Notified Bodies, Competent Authorities, and any associated Mutual Recognition Agreements (MRAs)) within the United Kingdom including Northern Ireland, the European Union, and its associated Member States. This role will be collaborating with IVD product development teams in the context of early phase drug development, providing regulatory strategy, regulatory writing and submission, authority interactions, and regulatory operational support.

The ideal candidate will have prior experience with Regulatory Affairs for IVD device submissions to both Notified Bodies and Competent Authorities in the context of drugs/biologics submissions, e.g., EU COMBINE, to also include IVDR Technical Documentation dossiers, and in carrying out regulatory activities and submissions independently or with minimal supervision.

You may lead or work as part of an internal regulatory or cross-functional team depending on the size and nature of project. You will also contribute to ICON Regulatory Affairs through your understanding of EU, Member State, and UK Regulatory process and interpretation of guidelines to develop best practices. This also includes Regulatory Project Management experience for timely and accurate completion of assigned projects and for timely identification of issues including the need for change orders. This role will also maintain an accurate record of the time associated with each allocated activity and ensure compliance with all timekeeping and tracking systems, including proficiency with Project Management software applications, e.g., MS Project.

You will need:
• Prior experience with Regulatory Affairs for IVD device submissions in the context of drugs/biologics submissions.
• Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail. This includes Regulatory Project Management and associated software.
• Excellent written and communication skills;
• Good written and spoken English;
• Proficiency in the use of Microsoft Office, proficiency in Project Management software applications, e.g., MS Project; and a
• Bachelor’s degree, or local equivalent, in an applicable scientific discipline, or equivalent experience qualification. Masters’ degree or higher in the sciences, preferred.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.