IVDR Regulatory Strategy Lead – Remote/Europe

Parexel; España; Remote; EUR 90,000 - 130,000; Full time

Job summary

Parexel is seeking an experienced Regulatory Affairs professional to lead IVD regulatory strategy across EU markets. You will drive performance evaluation study strategies, manage technical documentation, coordinate global submissions with cross-functional teams, and guide project teams through EU IVDR, ISO 13485, and ISO 20916 requirements to enable timely approvals.

The role can be home or office based across Europe, allowing interactions with health authorities and notified bodies to ensure

Qualifications

• Minimum 5+ years of experience in regulatory affairs for IVD.
• In-depth knowledge of EU IVDR, ISO 13485 and ISO 20916.
• Fluent in English, written and spoken.

Responsibilities

• Develop regulatory strategies for IVD products across EU markets.
• Prepare and manage technical documentation for regulatory submissions.
• Represent regulatory affairs in cross-functional teams and governance meetings.
• Lead interactions with health authorities and notified bodies for CE marking.

Skills

IVD RA experience

EU IVDR

EU MDR knowledge

English fluent

Regulatory submissions

Education

Life sciences degree

Tools

Veeva

TrackWise

Job description

Parexel is seeking an experienced Regulatory Affairs professional to lead IVD regulatory strategy across EU markets. You will drive performance evaluation study strategies, manage technical documentation, coordinate global submissions with cross-functional teams, and guide project teams through EU IVDR, ISO 13485, and ISO 20916 requirements to enable timely approvals.

The role can be home or office based across Europe, allowing interactions with health authorities and notified bodies to ensure