EU Medical Device Safety Leader

IQVIA Inc; Warszawa; On-site; PLN 310,000 - 659,000; Full time

Job summary

IQVIA MedTech is seeking an experienced Safety leader to oversee a growing European team responsible for medical device safety activities across clinical studies. The role combines technical and operational leadership to ensure EU safety reporting, quality and client delivery.

You will build and mentor Safety Specialists and Managers, drive staffing, budgets and performance, and partner with the US Safety team to resolve complex regulatory and client issues.

Qualifications

• Bachelor's degree in health science or related field, or equivalent experience.
• 10+ years of progressive Safety or clinical safety experience in CRO or Medical Device environment.
• Experience supporting Medical Device clinical studies in Europe.
• Knowledge of EU medical device safety requirements and EU safety reporting to Ethics Committees and Competent Authorities.
• 3–5 years of leadership/people-management experience.
• Experience leading Safety professionals and managing priorities across multiple programs or studies.

Responsibilities

• Provide senior leadership for safety activities supporting European studies.
• Oversee expedited and periodic EU safety reporting to Ethics Committees and Authorities.
• Oversee preparation and delivery of annual and periodic safety/progress reports.
• Serve as a Safety SME for clients, internal stakeholders, operational teams, and partners.
• Provide guidance on European Medical Device safety requirements and ensure compliance with regulatory, contractual, quality, and reporting requirements.
• Partner with US Safety team and cross-functional leaders to resolve complex issues.
• Lead, develop, and manage a team of Safety Specialists and Safety Managers.
• Support staffing, resource allocation, and budgeting for safety programs.
• Represent Safety in governance meetings, steering committees, and client forums.

Skills

Safety leadership

European regulatory knowledge

Leadership and people management

Client relationship management

Strategic program leadership

Operational management

Education

Bachelor's degree in health science or related field

Job description

IQVIA MedTech is seeking an experienced Safety leader to oversee a growing European team responsible for medical device safety activities across clinical studies. The role combines technical and operational leadership to ensure EU safety reporting, quality and client delivery.

You will build and mentor Safety Specialists and Managers, drive staffing, budgets and performance, and partner with the US Safety team to resolve complex regulatory and client issues.