Associate Regulatory Affairs Director at IQVIA

Reading, England, United Kingdom

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Clinical Research, Life SciencesIndustries

Requirements

Minimum 8 years of experience in regulatory affairs or medical device submissions
Strong knowledge of EU MDR, ISO 14155, and relevant regulatory frameworks
Proven experience managing multi-country clinical submissions and working with Competent Authorities and Ethics Committees
Exceptional written and verbal communication skills

Responsibilities

Lead the drafting and lifecycle management of Clinical Investigation Plans (CIP)
Prepare and maintain Master Patient Informed Consent (PIC) Forms in alignment with EU MDR and local regulatory requirements
Develop and manage Investigational Medical Device Dossiers and Investigator’s Brochures
Draft and manage Safety Plans and oversee Safety Reporting for both prospective and post-market studies
Prepare Clinical Study Progress Reports and Close-Out Reports
Draft, finalize, and manage Master Submission Documents for National Competent Authorities, Ethics Committees, and IRBs/IECs
Review and revise sponsor-provided submission documents to ensure regulatory compliance and consistency
Prepare and manage Amendment Submission Documents for protocol or study changes

Skills

EU MDR

ISO 14155

Clinical Investigation Plans

Informed Consent Forms

Investigational Medical Device Dossiers

Investigator’s Brochures

Safety Plans

Safety Reporting

Clinical Study Reports

Regulatory Submissions

Ethics Committees

IRBs

Amendment Submissions

Multi-country submissions

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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