Regulatory Affairs Specialist - Medical Devices
TA Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please click here to view live vacancies.
Any UK location - Remote or Office based
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
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 knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, 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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
.png)
Teaser label
IndustryContent type
BlogsPublish date
08/25/2025
Summary
Careers in Pharmacovigilance Pharmacovigilance, also known as drug safety, is one of the most important pillars of modern medicine. It ensures that once a medicine is developed, tested, and appro
.png)
Teaser label
Our PeopleContent type
BlogsPublish date
08/14/2025
Summary
A Leader’s Journey: Karen Hahn on Growth, Culture and the Future of ICON Mexico Karen Hahn’s career at ICON has unfolded over more than 15 years, shaped not by a rigid plan, but by openness to ch
.png)
Teaser label
Inside ICONContent type
BlogsPublish date
08/07/2025
Summary
Building a Career at ICON: A Conversation with Susie McEvoy, Senior VP of HR At ICON, career journeys are rarely linear – and Susie McEvoy’s story is a powerful example of that. From joining as a
Similar jobs at ICON
Salary
Location
Mexico City
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Mexico City
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Drug Safety
Job Type
Permanent
Description
As a Graduate Pharmacovigilance Assocaite you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with a
Reference
2025-122062
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Mexico City
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Mexico City
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Drug Safety
Job Type
Permanent
Description
As a Graduate Pharmacovigilance Assocaite you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with a
Reference
2025-122061
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
US, Blue Bell (ICON)
Location
Blue Bell
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
What you will be doing: The L-LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties
Reference
JR134830
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
US, Blue Bell (ICON)
Location
Blue Bell
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
What you will be doing: The L-LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties
Reference
JR134831
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
Ireland, Dublin
Department
Information technology
Location
Dublin
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Analyst
Job Type
Permanent
Description
About the role:Office Hybrid - 60% office-based in Leopardstown, Dublin 18; 40% remote.We are currently recruiting an experienced and driven Information Security Manager to work across key functions w
Reference
JR130347
Expiry date
01/01/0001
Author
Maya KatsarskaAuthor
Maya KatsarskaSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical
Reference
2025-122020
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio Sanquiz