CER Project Lead, Clinical Evaluations (Regulatory)

Regulatory Jobs; California; Sur place; USD 90 000 - 180 000; Plein temps

Avantages offerts par ce poste

Training & development

Competitive compensation

Health care & wellness

Paid time off

401(k) retirement

Résumé du poste

Abbott is a global healthcare leader seeking a Regulatory Project Manager, Clinical Evaluations to drive CER development and regulatory submissions for CE marking across EU MDR guidelines.

The role leads CER Writers, ensures timely deliverables, and collaborates with Regulatory Affairs, R&D, and Quality teams to strengthen the clinical evaluation process and ensure patient safety and device performance throughout product lifecycles.

Qualifications

• Bachelor's Degree is required; sciences/engineering/medical fields preferred.
• Minimum 3 years in clinical research, regulatory, or quality systems.

Responsabilités

• Ensure CERs and related documents are written and edited to support regulatory submissions.
• Manage CER Medical Writers and track deliverables and timelines.
• Contribute to Notified Body responses and submission strategies.
• Coordinate with Regulatory Affairs, R&D, Clinical R&D, Quality, and external vendors.
• Provide strategic guidance on regulatory requirements for clinical data and evaluations.
• Support audits, CAPAs, and quality metrics related to CER processes.
• Develop and update policies for the clinical evaluation process and train staff.

Connaissances

Regulatory knowledge

Project management

Written communication

Cross-functional collaboration

Formation

Bachelor's Degree

Description du poste

Abbott is a global healthcare leader seeking a Regulatory Project Manager, Clinical Evaluations to drive CER development and regulatory submissions for CE marking across EU MDR guidelines.

The role leads CER Writers, ensures timely deliverables, and collaborates with Regulatory Affairs, R&D, and Quality teams to strengthen the clinical evaluation process and ensure patient safety and device performance throughout product lifecycles.