CER Project Manager, EU Medical Device Regulation

Abbott; United States; Presencial; USD 120.000 - 170.000; Tempo integral

Resumo da vaga

Abbott is seeking a Regulatory Project Manager, Clinical Evaluations (CER PM) in Sylmar, CA. This role combines scientific methodology, device regulations, and product knowledge to support EU CE marking submissions and ongoing CE maintenance for Abbott medical devices.

The CER PM will lead CER writers, guide CER development, and collaborate with Regulatory Affairs, R&D, and Quality teams to ensure safety and performance data supports regulatory decisions.

Qualificações

• Bachelor's degree in sciences, medicine, or similar field required.
• Minimum 3 years of scientific or research background with relevant training.

Responsabilidades

• Ensure CER processes align with regulatory requirements and guidelines.
• Oversee CER Medical Writers and manage timelines for deliverables.
• Review and edit sections of Clinical Evaluation Reports and related documents.
• Lead regulatory responses to Notified Body questions.
• Coordinate document exchange among Regulatory Affairs, R&D, Clinical, and QA teams.
• Provide strategic regulatory guidance on clinical data for new products.
• Support audits and corrective action tracking related to CER processes.
• Develop and update CER-related policies and train staff.

Conhecimentos

Regulatory knowledge

Medical writing oversight

Cross-functional collaboration

Project management

CER / clinical evaluation

Formação

Bachelor's degree in sciences/medicine

Descrição da vaga

Abbott is seeking a Regulatory Project Manager, Clinical Evaluations (CER PM) in Sylmar, CA. This role combines scientific methodology, device regulations, and product knowledge to support EU CE marking submissions and ongoing CE maintenance for Abbott medical devices.

The CER PM will lead CER writers, guide CER development, and collaborate with Regulatory Affairs, R&D, and Quality teams to ensure safety and performance data supports regulatory decisions.