Senior Project Manager, Clinical Evaluation

Abbott • Los Angeles, CA

4d • $90,000 - $180,000 • Onsite

About The Position

Abbott is seeking a Project Manager, Clinical Evaluation in Sylmar, California, to support the Cardiac Rhythm Management product lines. The role combines scientific and research methodology, medical device regulations and guidelines, and product and therapeutic-area knowledge to support EU regulatory submissions for CE Marking of new devices and maintaining CE Marks for existing devices. Work is conducted in accordance with applicable EU regulations and guidance, including MEDDEV 2.7/1 Rev 4, MDD, AIMDD, MDCG guidance documents, and EU MDR 2017/745.

The Clinical Evaluation Report (CER) Project Manager is a subject matter expert on clinical evaluation regulations and documents, including CEPs, CERs, PMS Plans, PMCF Plans and Reports, and SSCPs. The role oversees internal and external CER Medical Writers and guides the development, updating, and revision of CERs and related documents to support ongoing evaluation of medical-device safety and performance. It involves gathering relevant safety, performance, adverse-event, and risk/benefit information across functions and may include process improvement, risk assessment and management, review of regulatory and informational documents, participation on product-development teams, procedure development, and interaction with regulatory agency representatives. The position contributes to new product development and the continuous lifecycle evaluation of devices. It reports to the Global Regulatory Operations Senior Manager for Clinical Evaluations.

Requirements

• Bachelor’s degree required, or an equivalent combination of education and work experience.
• At least 3 years of experience in the specified scientific/research background and capabilities.
• Scientific/research background with training and a degree in science, engineering, or medical fields, and understanding of research design, methodology, and statistics.
• Thorough understanding of EU MDR 2017/745, MDD 93/42/EEC, AIMDD 90/385/EEC, MEDDEV 2.7/1 Rev 4, MDCG guidance on clinical evaluations, SSCP, PMCF plans and reports, and other relevant medical-device, clinical-study, and quality-system guidance, regulations, standards, and guidelines.
• Project management and/or people-management experience.
• Effective written, verbal, and presentation skills in technical and clinical applications.
• Strong command of medical and surgical terminology.
• Demonstrated ability to adapt to changing priorities and competing demands.
• Highly developed interpersonal skills and strong attention to detail.
• Ability to travel as needed; the posting specifies travel of 5% of the time.

Nice To Haves

• Degree in sciences, medicine, or a similar discipline.
• Certification such as RAC or PMP.
• Master’s degree, RN, PharmD, PhD, or MD.
• Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), or Good Manufacturing Procedures (GMP).
• Experience with medical devices in CRM or Heart Failure, or other active implantable devices.
• Audit experience in a front-room or back-room role.
• 5–7+ years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems in the medical-device or pharmaceutical industry.
• 3–5+ years of experience writing, reviewing, or leading development of CERs and related documents under MEDDEV 2.7/1 Rev 4, MDD 93/42/EEC, AIMDD 90/385/EEC, and EU MDR 2017/745.

Responsibilities

• Comply with applicable corporate and divisional policies and procedures.
• Manage CER Medical Writers’ document writing and editing work and deliverable timelines, ensuring deadlines are met.
• Review, edit, and write portions of Clinical Evaluation Reports and associated documents as needed.
• Participate in or lead development of regulatory responses to Notified Body questions following submission review.
• Facilitate communication and document exchange among internal stakeholders and external vendors, including CROs, Medical Writers, and Physician Reviewers.
• Provide strategic guidance to new-product-development and sustaining teams on regulatory requirements for clinical data and clinical evaluations.
• Participate in and support audits and responses to audit findings, including root cause analysis, preventive and corrective actions, effectiveness monitoring, and other quality metrics.
• Develop and update policies for clinical evaluation processes and procedures as appropriate, and train key personnel.
• Make independent decisions on CER-related regulatory issues.
• Support EU regulatory submissions for CE Marking of new devices and maintenance of CE Marks for existing devices.
• Oversee development, updates, and revisions of CERs and associated clinical evaluation documents.
• Work cross-functionally to identify and obtain relevant documentation and data regarding device safety, performance, adverse events, and risk/benefit profiles.

Benefits

• Training and career development, including onboarding programs for new employees and tuition assistance.
• Competitive compensation, incentives, and retirement plans.
• Medical, dental, and vision coverage, wellness programs, and occupational health programs.
• Paid time off.
• 401(k) retirement savings plan with a company match.
• Company stability and involvement in local communities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior