Regulatory & Start-up Manager m/w/d - ( Office or Home based, Germany or Belgium) - IQVIA Medtech

IQVIA MedTech (IQM) 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 Manager to join our team in Germany or Belgium.

This position is permanent, full time and can be office based in Antwerp or Frankfurt or home based in Germany or Belgium.

Basic Functions:

• Ensures the regulatory submissions to Ethical Committees (EC), Competent Authorities (CA) and other applicable bodies within clinical medical device studies are performed in compliance with relevant regulations and applicable guidelines (e.g. ICH-GCP, ISO 14155, MDR, FDA 21 CFR),  IQVIA MedTech SOPs and agreements with the client. 
• Guides, supervises and evaluates the performance of the Regulatory & Start-up Specialists.
• Manages the overall regulatory-related activities in a clinical project in order to minimize possible risks related to its execution.
• Ensure continuous follow-up on regulatory updates and application of the most current regulations in the day-to-day work of the department and IQM team.

Knowledge, skills and abilities:

• Higher educational degree (BSc, MSc) in a medical or science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.

• At least five years of clinical research experience with two years in a medical device/drug clinical submissions or study start-up related function.
• Equivalent combination of relevant education and experience.
• In depth knowledge of clinical research process, medical terminology, ICH-GCP, GDPR, ISO 14155 and applicable FDA/EU regulations and guidelines.
• Excellent written and verbal communication skills.
• Fluent in English, by preference in more languages.
• Excellent attention to detail, planning and organizational skills.
• Ability to reason independently and recommend specific solutions in clinical settings.
• Ability to work independently, pro-actively, problem-solving, prioritize effectively and work in a matrix team environment required. 
• Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
• Advanced computer literacy and skills in working with Microsoft Office (Word, Excel, PowerPoint) required

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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.