Regulatory & Start Up Specialist - Medical Devices, Hungary

IQVIA MedTech intelligently connects the right insights, streamlined technology and deep MedTech expertise to help enhance healthcare outcomes of the medical device and in vitro diagnostics industry.

For our Hungarian office, we are looking for a Regulatory and Site Activation Specialist 2, ideally with local medical devices submission experience.

Job Profile Summary

Prepares, performs and follows-up on submissions to National Competent Authorities (NCAs), Ethical Committees (ECs), Institutional Review Boards (IRB) and other reviewing bodies according to the relevant legislation and guidelines for clinical trials with medical devices (e.g. ICH-GCP, ISO 14155:2020, MDR, FDA 21 CFR) under supervision of the Regulatory & Start-up Manager.

Main responsibilities:

• Search and verifies NCA/EC/IRB submission requirements.
• Drafts NCA/EC/RIB submission documents (e.g. application form, ICF, ...).
• Prepares NCA/EC/IRB and other applicable submission packages.
• Follows-up on development and collection of required regulatory documentation.
• Ensures timely filing of submission documents.
• Ensures regulatory tracking systems/databases remain updated.
• Follows-up on submission status and ensures resolution of all questions and comments under supervision of the Regulatory & Start-up Manager.
• Acts as an intermediary between the involved different parties, which may include IQVIA MedTech employees, Regulatory Authorities, Reviewing Committees, third party vendors (e.g. consultants, translation agencies), participating site staff (e.g. investigators, study coordinators) and clients.
• Pro-actively identifies regulatory related issues and discuss strategies with the Regulatory & Start-up Manager.
• Reports on activities and NCA/EC/IRB status in a timely fashion to the Regulatory & Start-up Manager.
• Assures adherence to Good Clinical Practices and compliance with all IQVIA MedTech SOPs, study procedures and regulatory requirements.
• Attends study-related, company, departmental, and external meetings, as required.
• Ensures all study deliverables are completed per IQVIA MedTech and study timelines.

Qualifications:

• You have a (para-) medical or scientific degree and by preference relevant experience in clinical research and clinical trial submissions.
• Fluent in English and Hungarian is a must.
• Excellent written and verbal communication skills.
• Excellent planning and organizational skills with proven time-management capability.
• Detail-oriented and pro-active with a strong analytical and problem-solving mindset.
• Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
• Able to handle several priorities within multiple, complex trials.
• Able to reason independently and recommend specific solutions in clinical settings.
• Able to work independently, prioritize, and work within a matrix team environment.
• Experience with standard Microsoft Office programs.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com