Regulatory & Start-Up Specialist, (Germany, Homebased) - IQVIA MedTech
IQVIA Holdings Inc.
IQVIA MedTech Clinical Solutions, including Genae which is a fully owned business unit of IQVIA, specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products.
IQVIA MedTech’s focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and patients.
We have a vacancy within our Clinical Regulatory and Start-up Team for an (experienced) permanent Regulatory & Start-up Specialist to join our team in EU.
Prepares, performs and follows-up on submissions to National Competent Authorities (NCAs), Ethical Committees (ECs) and other reviewing bodies according to the relevant legislation and guidelines for clinical trials with medical devices (e.g. ICH-GCP, ISO 14155, MDR, FDA 21 CFR) under supervision of the Regulatory & Start-up Manager.
- Search and verifies NCA/EC submission requirements.
- Drafts NCA/EC submission documents (e.g. application form, ICF, …).
- Prepares NCA/EC 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, Competent Authorities, Ethical 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 EC/NCA 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.
Knowledge, skills and abilities:
- You have a (para-) medical or scientific degree and by preference relevant experience in clinical research and clinical trial submissions.
- Fluent in English, by preference in more languages.
- 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
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.