EU Medical Device Safety Director - Lead & Strategy

IQVIA; Berchem; On-site; EUR 130,000 - 260,000; Full time

Job summary

IQVIA MedTech seeks an experienced Safety leader to oversee a growing EU team delivering safety activities for Medical Device clinical studies. This role focuses on expedited and periodic safety reporting to EU Ethics Committees and Competent Authorities, with annual progress reporting and strong client delivery.

The candidate will lead and grow a Safety organization, ensuring regulatory compliance, operational excellence, and proactive risk management across programs in Europe and beyond.

Qualifications

• Bachelor’s degree in health science, life science, nursing, pharmacy, or related discipline.
• At least 10 years of progressive safety, clinical safety, or related experience within a CRO or Medical Device environment.
• Experience with European Medical Device safety requirements and EU safety reporting, including Ethics Committees and Competent Authorities.

Responsibilities

• Provide senior leadership for safety activities supporting European medical device clinical studies.
• Oversee expedited and periodic safety reporting to EU Ethics Committees and Competent Authorities.
• Lead safety program delivery, governance, and client-facing safety initiatives across multiple programs.
• Manage and develop Safety Specialists and Safety Managers, ensuring staffing and performance.
• Partner with US Safety and cross-functional teams to resolve complex operational and regulatory issues.

Skills

Leadership

Stakeholder management

Regulatory knowledge

Education

Bachelor’s degree

Job description

IQVIA MedTech seeks an experienced Safety leader to oversee a growing EU team delivering safety activities for Medical Device clinical studies. This role focuses on expedited and periodic safety reporting to EU Ethics Committees and Competent Authorities, with annual progress reporting and strong client delivery.

The candidate will lead and grow a Safety organization, ensuring regulatory compliance, operational excellence, and proactive risk management across programs in Europe and beyond.