Clinical Evaluation - Senior Project Manager

5-7 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

Clinical Evaluation - Senior Project Manager

Location: Plano, TX | Austin, TX | Santa Clara, CA | Sylmar, CA | Maple Grove, MN

About Abbott

Abbott is a global healthcare leader helping people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines. With over 114,000 colleagues across 160+ countries, we deliver life-changing technologies every day.

Working at Abbott

At Abbott, you can:

Do meaningful work that makes a difference.
Grow your career with international opportunities.
Care for yourself and your family with comprehensive benefits.
Be your authentic self and thrive.

Employee Benefits include:

Free medical coverage (Health Investment Plan PPO) for eligible employees.
Excellent retirement savings plan with strong employer contributions.
Tuition reimbursement, student debt support (Freedom 2 Save), and FreeU bachelor’s degree program.
Recognition as one of the best places to work globally (diversity, working mothers, female executives, and scientists).

The Opportunity

We are seeking a Clinical Evaluation - Senior Project Manager to support Abbott’s Neuromodulation product lines. This role combines expertise in research methodology, regulatory requirements, and product knowledge to support EU regulatory submissions for CE Marking (new and existing devices) under MEDDEV 2.7/1 Rev 4, MDD, AIMDD, MDCG guidance, and EU MDR 2017/745.

What You’ll Work On

Manage and oversee Clinical Evaluation Report (CER) development by medical writers.
Set project deliverables, timelines, and ensure on-time delivery.
Review, edit, and contribute to CERs and related documents.
Coordinate communication between internal teams (Regulatory, R&D, Clinical Affairs, Quality, Risk Management, etc.) and external vendors (CROs, writers, physician reviewers).
Provide regulatory guidance on clinical data and evaluations for new and existing products.
Lead responses to Notified Body queries during submission reviews.
Develop/update policies and train personnel on CER processes.
Support audits, corrective actions, and compliance with internal and external standards.
Function as an independent decision-maker on CER-related regulatory matters.

Required Qualifications

Bachelor’s degree.
2+ years of experience in regulatory affairs (or related areas: quality assurance, R&D, scientific affairs, operations).
3+ years of experience in a regulated industry (medical products, devices, nutritionals).
Knowledge of product laws, clinical research, and regulatory guidelines.
Strong analytical, organizational, and project management skills.
Ability to follow scientific arguments, assess data needs, and resolve regulatory issues.

Preferred Qualifications

Bachelor’s degree in science, engineering, or medical field (advanced degree preferred).
Strong background in research, statistics, and clinical methodologies.
In-depth knowledge of EU MDR 2017/745, MDD 93/42/EEC, AIMDD 90/385/EEC, MEDDEV 2.7/1 Rev 4, MDCG guidance.
5–7+ years of experience in clinical research, regulatory, or quality systems (medical devices/pharma).
3–5+ years of direct CER writing, reviewing, or management.
Strong presentation, interpersonal, and communication skills.
Project management or people management experience.
Certifications (e.g., RAC, PMP) are a plus.

Compensation

Base Pay Range: $75,300 – $150,700 (may vary by location).

Why Join Us

Every day, Abbott’s medical devices improve lives by helping people manage diabetes, heart disease, chronic pain, and movement disorders.
Our technologies impact thousands of lives daily, enabling healthier, fuller living.

Equal Opportunity

Abbott is an Equal Opportunity Employer committed to diversity and inclusion.

👉 Learn more about benefits: abbottbenefits.com
👉 Connect with us: abbott.com | Facebook: @Abbott | Twitter: @AbbottNews

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Clinical Evaluation - Senior Project Manager

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