Job Title
A career in regulatory compliance is a great choice for individuals who want to make a meaningful impact in the healthcare industry. As a Regulatory Contact Study Start-Up (SSU)/Regulatory Lead (Clinical Studies), you will be responsible for ensuring that clinical studies are conducted in accordance with relevant laws and regulations.
The ideal candidate will have excellent communication and project management skills, as well as the ability to work effectively in a team environment. You will be responsible for performing local clinical study application submissions, preparing and translating submission documents, and staying up-to-date on local regulatory requirements.
Additionally, you will provide guidance on regulatory requirements to internal and external stakeholders, and may also contribute to and coordinate regulatory and EC clinical study application submissions for multi-country trials.
As a CRA, you will monitor and manage clinical trials in compliance with protocol, ICH-GCP/ISO 14155, SOPs, and regulations. This includes conducting source data review, source data verification, and reviewing case report forms.
Strong analytical and problem-solving skills are essential for this role, as well as the ability to work independently and prioritize tasks effectively.
With LINK Medical, you will have the opportunity to work with a dynamic team of professionals who are passionate about making a difference in the healthcare industry.
Become a part of our global network and take your career to the next level.
* Experience in clinical trials submissions for both investigational medicinal products and medical devices locally and preferably also internationally incl. UK
* Knowledge of ICH-GCP, ISO14155 and national regulations
* Fluent in the local language and English
* Strong writing and IT skills
We offer:
* A competitive compensation package
* Opportunities for professional development and growth
* A collaborative and supportive work environment
Apply now by submitting your application in English.