Senior Project Manager, Clinical Evaluation
About The Position
Abbott is seeking a Clinical Evaluation Report (CER) Project Manager to support Cardiac Rhythm Management product lines. The position combines scientific and research-methodology knowledge, medical-device regulatory expertise, and product and therapeutic-area knowledge to support EU regulatory submissions for CE Marking new devices and maintaining CE Marking for existing devices. Work is performed in accordance with applicable medical-device directives, regulations, and guidance, including MEDDEV 2.7/1 Rev 4 and EU MDR 2017/745. The CER Project Manager is a subject matter expert on clinical-evaluation regulations and related documentation, including CEPs, CERs, PMS Plans, PMCF Plans and Reports, and SSCPs. The role oversees internal and external medical writers and guides the development, updating, and revision of CERs and associated documents used to evaluate the safety and performance of Abbott medical devices in the EU and other geographies recognizing the CE Mark. The manager works cross-functionally to identify and obtain relevant safety, performance, adverse-event, and risk/benefit documentation and data. The role may also contribute to process improvement, risk assessment and management, and review of materials such as Clinical Development Plans, Instructions for Use, and patient handbooks. The CER Project Manager may participate in product-development core teams, CER-related procedure development and revision, and interactions with regulatory-agency representatives. This position contributes to new product development and the ongoing lifecycle evaluation of device safety, performance, and risk/benefit profiles. It reports to the Global Regulatory Operations Senior Manager for Clinical Evaluations.
Requirements
- Bachelor's degree required; a degree in sciences, medicine, or a similar discipline is highly preferred, or an equivalent combination of education and work experience.
- At least 3 years of scientific or research background, including 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 clinical-evaluation guidance, SSCPs, PMCF plans and reports, and other medical-device, clinical-study, and quality-system guidance, regulations, standards, and guidelines.
- Experience in project management and/or people management.
- Effective written, verbal, and presentation skills in technical and clinical applications.
- Strong command of medical and surgical terminology.
- Demonstrated ability to adapt to shifting priorities and competing demands.
- Highly developed interpersonal skills and strong attention to detail.
- Able to travel as needed, less than 10%.
Nice To Haves
- 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 Cardiac Rhythm Management (CRM), 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 in accordance with 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, including document content and delivery timelines, and ensure deadlines are met.
- Review, edit, and write portions of Clinical Evaluation Reports and associated documents as needed.
- Participate in and/or lead the 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 audit responses, including root-cause analysis, corrective and preventive actions, effectiveness monitoring, and other quality metrics.
- Develop and update policies, processes, and procedures relating to clinical evaluation, and train key personnel on them.
- Make independent decisions on CER-related regulatory issues.
- Contribute as needed to process improvement, risk assessment and management, review of regulatory and informational documents, product-development core teams, procedure development and revision, and interactions with regulatory-agency representatives.
Benefits
- Training and career development, including onboarding programs for new employees and tuition assistance.
- Competitive compensation, incentives, and retirement plans.
- Medical, dental, vision, wellness, and occupational health programs.
- Paid time off.
- 401(k) retirement savings with a generous company match.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
