CER Project Manager - EU MDR Regulatory Lead

Abbott; Los Angeles (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Health benefits

Training and career development

401(k) retirement plans

Paid time off

Tuition assistance

Job summary

Abbott in Sylmar, CA is seeking a Regulatory CER Project Manager to oversee clinical evaluation reports and related documentation for EU CE marking and ongoing device evaluation. You will guide internal and external writers, coordinate with Regulatory Affairs, and manage CER activities across product lines.

The role requires deep knowledge of EU MDR 2017/745, MDD, and related MEDDEV guidance, with 5–7+ years in clinical research or regulatory affairs. Travel up to 10% may be required.

Qualifications

• Bachelor’s Degree in sciences, medicine, or similar discipline
• Minimum 3 years: scientific/research background, training in science/engineering or medical fields
• Strong understanding of EU MDR 2017/745, MDD 93/42/EEC; MEDDEV 2.7/1 Rev 4, and related guidelines
• Project management and/or management of people experience
• Excellent written, verbal and presentation skills; strong medical terminology

Responsibilities

• Ensure CERs and related documents are written/edited to support regulatory submissions
• Lead CER-related procedures with internal/external writers
• Coordinate responses for Notified Body questions and audit findings
• Regulatory guidance on clinical data and evaluations to product development teams
• Interact with cross-functional teams and external vendors as needed
• Develop/update policies for the clinical evaluation process and train personnel
• Act independently as decision-maker on CER regulatory issues

Skills

CER writing

Regulatory guidance

Cross-functional collaboration

Regulatory strategy

Education

Bachelor’s Degree in sciences/medicine

Master’s Degree or equivalent preferred

Job description

Abbott in Sylmar, CA is seeking a Regulatory CER Project Manager to oversee clinical evaluation reports and related documentation for EU CE marking and ongoing device evaluation. You will guide internal and external writers, coordinate with Regulatory Affairs, and manage CER activities across product lines.

The role requires deep knowledge of EU MDR 2017/745, MDD, and related MEDDEV guidance, with 5–7+ years in clinical research or regulatory affairs. Travel up to 10% may be required.