Regulatory Affairs Specialist MDDR
TA Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please click here to view live vacancies.
Regulatory Affairs Specialist - IVD/MDDR
At ICON, it's our people that set us apart.
As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?
We are looking for passionate, resilient, and inspiring individuals to join our team. As a Regulatory Affairs Specialist you will be responsible for assembling/preparing technical documents for IVD. You will be working independently but as part of a cross functional team.
The role
- Effectively perform Regulatory Affairs activities on regulatory projects and/or clinical trials being undertaken by ICON Assist the team with study maintenance activities by providing administrative and tracking support
- Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken
- Prepare and/or support proposals and bids.
- Participate in regulatory and/or clinical trial project teams. Assist with the preparation, writing and filing of appropriate FDA pre-market submission, participates in FDA Pre-Submission Meetings, assist with the preparation of additional data/information requested by regulatory agencies
- Plan and track designated project activities including financial tracking
- Initiate product research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements
- Contribute to scientific and regulatory documents and communication letters to Regulatory Authorities, in collaboration with Regulatory Project Lead or Functional Experts.
- Contribute to core regulatory submissions, either alone or in collaboration with Functional Experts.
- Advise on regulatory aspects of protocols and clinical trials.
- Contribute to regulatory submissions to support post-market administration/activities, e.g. preparation of variations to product approval either alone or in collaboration with Functional Experts. Support the regulatory assessment of proposed changes. Advise on regulatory aspects of post market activities
- Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within ICON
What you need
- Minimum of a Bachelor's degree, preferably in life sciences
- Minimum of 3 years' experience in related field
- Experience in the preparation of regulatory submissions and dossiers
- Ability to read and interpret design and verification documentation
- Prior R&D experience preferred
- Strong written and oral communication skills
Why join us?
Ongoing development is vital to us, and as the Regulatory Affairs Specialist you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.
ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.
EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin
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
05/29/2025
Summary
Blood Cancer Day Blood Cancer Day is a powerful reminder of the millions of individuals and families whose lives are affected by hematological malignancies every year. These diseases are complex,
.png)
Teaser label
IndustryContent type
BlogsPublish date
05/22/2025
Summary
World Schizophrenia Awareness Day 2025 Every year on 24 May, World Schizophrenia Awareness Day offers a vital opportunity to raise awareness, dismantle stigma, and celebrate the strength of individ
.png)
Teaser label
Inside ICONContent type
BlogsPublish date
05/08/2025
Summary
Standing Strong on Ovarian Cancer Day: ICON's Commitment to Advancing Care Ovarian cancer remains one of the most challenging gynaecologic malignancies, both in terms of detection and treatmen
Similar jobs at ICON
Salary
Location
Ireland, Dublin
Location
Dublin
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Accounting & Finance
Job Type
Permanent
Description
We are currently seeking a Revenue Manager to join our diverse and dynamic team. As a Revenue Manager at ICON, you will oversee the revenue management and financial reporting processes for clinical tr
Reference
JR131043
Expiry date
01/01/0001
Author
Damien KehirAuthor
Damien KehirSalary
Location
UK, Reading
Location
Reading
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team in a role dedicated to one of our most valued sponsors. . As a Senior CRA at ICON , you will pl
Reference
JR130205
Expiry date
01/01/0001
Author
Katty Barreto MaiaAuthor
Katty Barreto MaiaSalary
Location
Turkey
Department
Clinical Trial Management
Location
Turkey
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Site Engagement Liasion you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-119922
Expiry date
01/01/0001
Author
Yagmur YangozAuthor
Yagmur YangozSalary
Location
South Africa, United Kingdom, Spain, Romania
Department
Biometrics Roles
Location
Romania
South Africa
Spain
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
As a Senior Clinical Data Science Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Working within one of our newest
Reference
2025-118736
Expiry date
01/01/0001
Author
Jonathan CunliffeAuthor
Jonathan CunliffeSalary
Location
US, Salt Lake City (PRA)
Location
Multiple US Locations
Salt Lake City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Liasion
Job Type
Permanent
Description
ICON’s field-based Clinical Trial Liaisons are highly trained site engagement specialists who support clinical trials by providing scientific and clinical support to investigators and site staff to en
Reference
JR130270
Expiry date
01/01/0001
Author
Muna NelkeAuthor
Muna NelkeSalary
Location
Brazil, Sao Paulo
Location
Sao Paulo
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Liasion
Job Type
Permanent
Description
ICON’s field-based Clinical Trial Liaisons are highly trained site engagement specialists who support clinical trials by providing scientific and clinical support to investigators and site staff to en
Reference
JR130269
Expiry date
01/01/0001
Author
Diego ToniniAuthor
Diego Tonini