Remote IVD Regulatory Lead for EU IVDR Strategy

Parexel; United States; Remoto; USD 120.000 - 150.000; Tempo pieno

Descrizione del lavoro

Parexel is seeking an experienced Regulatory Affairs professional to lead IVD regulatory strategy, guiding performance evaluation studies and marketing authorizations. You will serve as the key regulatory representative for global project teams, with the role offering flexibility to work home or office-based in various European locations.

Responsibilities include developing regulatory strategies, preparing technical documentation, and coordinating with health authorities throughout the lifecycle

Competenze

• 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 and international regulatory framework for medical devices.
• Proven experience in global regulatory strategy and technical documentation for EU 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.

Mansioni

• Develop comprehensive regulatory strategies for performance evaluation studies.
• Support the preparation of technical documentation of IVD 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.

Conoscenze

Regulatory strategy

Global regulatory knowledge

Regulatory submissions

Communication

Formazione

University degree in scientific discipline

Strumenti

Veeva

TrackWise

Descrizione del lavoro

Parexel is seeking an experienced Regulatory Affairs professional to lead IVD regulatory strategy, guiding performance evaluation studies and marketing authorizations. You will serve as the key regulatory representative for global project teams, with the role offering flexibility to work home or office-based in various European locations.

Responsibilities include developing regulatory strategies, preparing technical documentation, and coordinating with health authorities throughout the lifecycle