Regulatory Affairs Specialist - Medical Devices
Any UK location - Remote or Office based
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.
Summary:
Working as part of our Regulatory Affairs department for Medical Devices, as Regulatory Affairs Specialist you will be working with manufacturing clients offering regulatory expertise. As part of a global team you be given opportunities to develop your knowledge of global regulations, under a well established leadership team.
The Role:
- Responsible for providing advice and support to the project team for regulatory operations aspects of the projects.
Manage and ensure maintenance of a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, co-workers, staff, etc.)
Maintain a strong customer service management approach with clients.
Lead project teams and advise departments on regulatory standards issues and strategies
Develop, write, and implement standards and procedures related to regulatory operations.
Identify client issues and develop alternative strategies for presentation to client consulting with other resources within organization as required
Participate actively in other business related projects (business opportunities, client specific issues, etc.) and planning.
Client consultation and preparation of quotes and is responsible for achieving utilization goals of the EU unit.
Review documents and advise clients on the adequacy and suitability of regulatory documentation, for example in relation to regulatory strategy, Investigator Brochures, Instructions for Use, clinical evidence submissions for CE Marking, clinical evaluations, post-market surveillance, Vigilance, Literature Reviews, Clinical Evaluation Reports, etc.
You will need:
Minimum of 3 years experience of regulatory affairs within medical devices
Experience in EU submissions.
Experience in medical device directive / active implantable medical device directive / medical device regulation.
Good knowledge of class 2 and 3 devices.
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.