CER Regulatory Project Manager — EU MDR Expert

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

Benefits offered by this job

Training and career development

Financial security and retirement

Health care and well-being

Paid time off

401(k) matching

Job summary

Abbott in Sylmar, CA is seeking a Project Manager, Clinical Evaluation to lead regulatory evaluations for medical devices. You will oversee CER writers, ensure timely CER development, and coordinate cross-functional teams across Regulatory Affairs, R&D, Clinical R&D, and Quality.

Requires a Bachelor's in sciences or medicine, 3+ years in regulatory/clinical research, and strong knowledge of EU MDR 2017/745. Travel up to 10% may be required.

Qualifications

• Bachelor's degree in sciences, medicine, or similar field.
• Experience in regulatory affairs for medical devices and clinical evaluations.
• Strong knowledge of EU MDR 2017/745, MDD, AIMDD, MEDDEV 2.7/1 Rev 4, and related guidance.
• Excellent written, verbal and presentation skills.

Responsibilities

• Ensure CER documents and related submissions meet timelines.
• Lead CER writers and coordinate with stakeholders.
• Develop regulatory responses for Notified Body questions.
• Communicate with cross-functional teams including Regulatory Affairs, R&D, Clinical R&D, A&P and Quality.
• Support audits and corrective actions as needed.
• Develop and update CER processes and train staff.
• Make CER regulatory decisions independently.

Skills

Project management

Regulatory affairs

CER writing

Medical terminology

Presentation skills

Education

Bachelor's degree

Master’s degree preferred

Job description

Abbott in Sylmar, CA is seeking a Project Manager, Clinical Evaluation to lead regulatory evaluations for medical devices. You will oversee CER writers, ensure timely CER development, and coordinate cross-functional teams across Regulatory Affairs, R&D, Clinical R&D, and Quality.

Requires a Bachelor's in sciences or medicine, 3+ years in regulatory/clinical research, and strong knowledge of EU MDR 2017/745. Travel up to 10% may be required.