Clinical Evaluation Project Manager – Clinical Scientist (Structural Heart Devices)
Location: Maple Grove, Minnesota, United States
Category: Regulatory Affairs / Clinical Affairs
Employment Type: Full-Time, On-Site
Experience Required: 7+ years in clinical research, regulatory affairs, or medical device quality systems
About Abbott
Abbott is a global healthcare leader delivering innovations that empower people to live healthier lives. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generics, impacting millions globally. With over 114,000 colleagues in 160+ countries, Abbott combines scientific expertise, regulatory excellence, and operational innovation to improve patient outcomes.
Abbott’s Structural Heart business is focused on advancing therapies for heart disease, enabling patients to live healthier, more active lives.
Role Overview
Abbott is seeking a Clinical Evaluation Project Manager – Clinical Scientist to join our Structural Heart team in Maple Grove, MN. This role combines scientific expertise, regulatory knowledge, and project management to support CE Marking submissions and maintenance of medical devices under European Union regulations (MDD 93/42/EEC, MDR 2017/745) and MEDDEV 2.7/1 Rev 4 guidelines.
The Project Manager (CER PM) serves as a subject matter expert in clinical evaluation processes, overseeing medical writers, guiding document development, and coordinating cross-functional teams. The role directly supports regulatory submissions, product lifecycle evaluation, and compliance with applicable guidelines for structural heart devices.
Key Responsibilities
Lead and manage medical writers in preparation and editing of Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), PMS/PMCF Plans, SSCPs, and PSURs.
Develop and manage project timelines using appropriate project management tools; communicate risks and mitigation strategies to cross-functional teams.
Analyze clinical, scientific, and risk data to inform regulatory submissions and ensure compliance with MEDDEV 2.7/1 Rev 4 and MDR requirements.
Prepare, review, and edit regulatory deliverables for CE Marking of new devices and maintenance of existing devices.
Support responses to Notified Body questions, audits, and inspections; participate in root cause analysis and corrective/preventive action implementation.
Facilitate communication between internal stakeholders (Regulatory Affairs, R&D, Clinical, Sales, Quality, Project Management) and external vendors (CROs, medical writers, reviewers).
Provide strategic guidance on regulatory requirements for clinical evaluation to product development and sustaining teams.
Independently manage CER-related regulatory decisions, ensuring timely submission and deliverables within budget.
Required Qualifications
Associates Degree (minimum, ±13 years of education) or equivalent experience.
Minimum 7 years of experience in clinical research, regulatory affairs, or quality systems in the medical device industry.
Strong written, verbal, and presentation skills for technical and clinical applications.
Project management experience and/or experience managing people.
Familiarity with clinical evaluation processes, clinical study data, and regulatory guidelines.
Preferred Qualifications
Bachelor’s, Master’s, or Doctorate degree in life sciences (nursing, medicine, biomedical engineering, pharmacy, or related).
Experience in structural heart or structural intervention devices.
Hands-on experience writing and reviewing CERs and regulatory submissions under MEDDEV 2.7/1 Rev 4 and MDR 2017/745.
Knowledge of ISO 13485, ISO 14971, ISO 14155, and quality system standards.
Certifications such as RAC or PMP are a plus.
Advanced analytical skills with ability to manage competing priorities and shifting project demands.
Strong attention to detail and ability to ensure deliverables meet timelines.
Why Join Abbott
Engage in cutting-edge medical device innovation for structural heart therapies.
Access to career development, training, and tuition assistance programs.
Comprehensive health and wellness benefits including medical, dental, vision, and occupational health programs.
Competitive compensation and retirement savings plans.
Be part of a company recognized globally for diversity, innovation, and employee development.
Learn more: www.abbottbenefits.com
Abbott is an Equal Opportunity Employer, committed to employee diversity and inclusion.
Base Salary: $86,700 – $173,300 (location-dependent)
Apply Now to join Abbott as a Clinical Evaluation Project Manager – Clinical Scientist.
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