Senior CER Project Manager: Clinical Evaluation (Med Devices)

Abbott (abbottcareers2 board); United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Abbott is a global healthcare leader seeking a Clinical Evaluations CER Project Manager in Sylmar, CA. The role combines scientific methodology, medical device regulations, and product knowledge to support EU CE marking submissions and ongoing CE maintenance for cardiac devices.

The CER PM oversees CER writers, guides CER development, and collaborates with Regulatory Affairs, R&D, quality, and external vendors.

Qualifications

• Bachelor's Degree is required. in sciences, medicine, or similar discipline highly preferred. Or an equivalent combination of education and work experience.
• Minimum 3 years: Scientific/research background; training and degree in science, engineering, or medical fields; understanding of research design, methodology, and statistics.

Responsibilities

• Compliance with applicable corporate and divisional policies and procedures.
• Manage CER Medical Writers' in writing and editing content of documents, and the timelines of these deliverables; must assure timelines are met.
• Review, edit, and write portions, as needed, of Clinical Evaluation Reports and associated documents.
• Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions.
• Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, A&P and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).
• Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development teams and sustaining teams.
• Participate in and support audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.
• Develop and update new policies, as appropriate, for processes and procedures relating to the clinical evaluation process, and train key personnel on them.
• Function independently as a decision-maker on CER-related regulatory issues.

Skills

Regulatory knowledge

Clinical evaluations

Education

Bachelor's Degree

Science/medical background

Job description

Abbott is a global healthcare leader seeking a Clinical Evaluations CER Project Manager in Sylmar, CA. The role combines scientific methodology, medical device regulations, and product knowledge to support EU CE marking submissions and ongoing CE maintenance for cardiac devices.

The CER PM oversees CER writers, guides CER development, and collaborates with Regulatory Affairs, R&D, quality, and external vendors.