Clinical Evaluation - Senior Project Manager

3 years

$75,300.00 – $150,700.00.

United States

10 Sept. 9, 2025

Job Description

Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Abbott – Clinical Evaluation Senior Project Manager

Company Overview:
Abbott is a global healthcare leader dedicated to helping people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in over 160 countries with the support of 114,000 colleagues.

Why Work at Abbott:
At Abbott, you can:

Do work that matters, grow, and learn.
Care for yourself and your family.
Be your true self and live a full life.

Benefits Include:

Career development with global opportunities.
Health coverage through the Health Investment Plan (HIP) PPO.
Competitive retirement savings plans with high employer contribution.
Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefits.
Recognition as a great place to work globally and for diversity, women in leadership, and scientific careers.

Medical Device Impact:
Our devices provide faster, more effective, and less invasive solutions. Examples include:

Glucose monitoring systems freeing over 500,000 people from routine fingersticks.
Innovative therapies for heart disease.
Solutions for chronic pain and movement disorders improving quality of life for thousands.

Position Overview

Job Title: Clinical Evaluation – Senior Project Manager
Locations: Plano, TX | Austin, TX | Santa Clara, CA | Sylmar, CA | Maple Grove, MN

This role will support Abbott’s Neuromodulation product lines and combine expertise in scientific methodology, medical device regulations, and product knowledge to manage regulatory submissions in the EU, including CE marking of new and existing devices.

Key Responsibilities

Manage and oversee CER Medical Writers’ development of Clinical Evaluation Reports (CERs) and related documents.
Set deliverables and project timelines; ensure timely completion.
Facilitate communication between internal stakeholders (Regulatory Affairs, R&D, Clinical Engineering, Quality, Post-market Surveillance, Marketing) and external vendors (CROs, Medical Writers, Physician Reviewers).
Review, edit, and write portions of CERs and associated documents.
Lead regulatory responses to Notified Body questions.
Provide strategic guidance on clinical evaluation and regulatory requirements.
Ensure compliance with corporate and divisional policies.
Participate in audits and support root cause analysis, corrective actions, and effectiveness monitoring.
Develop and update policies and procedures for clinical evaluation processes; train key personnel.
Function independently as a decision-maker on CER-related regulatory matters.

Required Qualifications

Bachelor’s Degree.
Minimum 2 years of experience in regulatory affairs or related areas (quality assurance, R&D support, scientific affairs, operations).
Minimum 3 years in a regulated industry (medical products, nutritionals). Higher education may substitute for experience.
Knowledge of applicable product laws and ethical guidelines.
Strong analytical, organizational, and problem-solving skills.
Ability to manage project plans and timelines.
Familiarity with scientific data analysis and regulatory requirements.

Preferred Qualifications

Bachelor’s or advanced degree in science, engineering, or medical fields.
Scientific/research background with understanding of research design, methodology, and statistics.
Deep understanding of EU MDR 2017/745, MDD 93/42/EEC, AIMDD 90/385/EEC, MEDDEV 2.7/1 Rev 4, MDCG guidance, SSCP, PMCF, and related international standards.
Project management experience and/or people management.
Strong presentation skills in clinical/technical applications.
Knowledge of medical and surgical terminology.
Ability to manage shifting priorities and competing demands.
5–7+ years in clinical research, clinical affairs, regulatory affairs, or quality systems in medical device/pharma.
3–5+ years writing or leading CER development in accordance with MEDDEV and EU MDR.
Professional certification (RAC, PMP) is a plus.

Compensation

Base Pay: $75,300 – $150,700 (varies by location).

Additional Information

Learn more about Abbott’s health and wellness benefits: Abbott Benefits
Connect with Abbott: Website, Facebook, Twitter

Equal Opportunity Employer: Abbott is committed to diversity and inclusion in the workplace.

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Clinical Evaluation - Senior Project Manager

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