IVDR Regulatory Lead for IVDs (Remote/Europe)

Parexel; Milano; On-site; EUR 85,000 - 120,000; Full time

Job summary

Parexel International is seeking an experienced Regulatory Affairs professional to lead IVD regulatory strategy, provide expert guidance on performance evaluation studies, and oversee regulatory paths for marketing authorisations with global project teams.

The role supports EU IVDR, ISO 13485 knowledge and interacts with health authorities; flexible location across Europe, including home or office.

Qualifications

• University degree in science or life sciences.
• Minimum 5+ years of regulatory affairs for IVD.
• Deep knowledge of EU IVDR, ISO 13485, ISO 20916.
• Experience with EU MDR and global regulatory frameworks.
• Excellent communication and English fluency.
• Experience with regulatory audits and inspections.

Responsibilities

• Develop regulatory strategies for performance evaluation studies.
• Prepare technical documentation for IVD products.
• Represent regulatory affairs in global project teams.
• Lead interactions with health authorities and notified bodies.
• Manage regulatory activities across development and marketing authorization.
• Maintain global regulatory databases with up-to-date information.
• Coordinate cross-functional submissions on schedule.
• Support continuous improvement and strategic planning.

Skills

Regulatory strategy

Regulatory affairs IVD

EU IVDR

ISO 13485

Regulatory audits

Regulatory submissions

English proficiency

Veeva

TrackWise

Education

Science degree

Tools

Veeva

TrackWise

Job description

Parexel International is seeking an experienced Regulatory Affairs professional to lead IVD regulatory strategy, provide expert guidance on performance evaluation studies, and oversee regulatory paths for marketing authorisations with global project teams.

The role supports EU IVDR, ISO 13485 knowledge and interacts with health authorities; flexible location across Europe, including home or office.