Regulatory Affairs Consultant: Medical Device IVDR - home or office based in various EU locations

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

We are seeking an experienced Regulatory Affairs professional to lead IVD (in vitro diagnostic devices) regulatory strategy. In this pivotal role, you will provide expert guidance on regulatory pathways for performance evaluation studies and marketing authorizations, and serve as the key regulatory representative for our global project teams.

The role can be home or office based in various European locations.

Key Responsibilities:

• Develop comprehensive regulatory strategies for performance evaluation studies.
• Support the preparation of technical documentation of IVDs products.
• Represent the regulatory affairs function in global project teams and governance meetings.
• Lead regulatory interactions with health authorities and notified bodies, including preparation of documentation and coordination of meetings.
• Manage regulatory activities throughout the IVD clinical development lifecycle and marketing authorization.
• Maintain global regulatory databases with accurate and current information.
• Coordinate with cross-functional teams to ensure timely and compliant regulatory submissions.
• Contribute to continuous improvement initiatives, innovation, and strategic planning within the regulatory function.

Skills And Experience:

• University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience related science discipline.
• Minimum 5+ years of experience in regulatory affairs for IVD.
• In-depth knowledge of EU IVDR, ISO 13485 and ISO 20916.
• Knowledge of EU MDR regulation, international regulatory framework and experience in medical devices would be a plus.
• Proven experience in global regulatory strategy and technical documentation preparation for EU (e.g., performance evaluation studies, CE certifications).
• Strong track record representing companies during regulatory audits and inspections.
• Excellent communication and interpersonal skills.
• Fluent in English, written and spoken.
• Proficiency with regulatory systems including Veeva and TrackWise would be a plus.