Senior Project Manager, Clinical Evaluation

Abbott

. Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports and associated documents; set deliverables and project timelines and ensure timelines are met.

Posted 4/3/2026full-timeSanta Clara • California, Minnesota • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports and associated documents; set deliverables and project timelines and ensure timelines are met.
Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).
Review, edit, and write portions, as needed, of Clinical Evaluation Reports and associated documents.
Draft and/or lead the development of regulatory responses for Notified Body and regulators’ questions upon review of submissions.
Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development teams and sustaining teams.
Compliance with applicable corporate and divisional policies and procedures.
Participate in and support internal and external audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.
Develop and update new policies, as appropriate, for processes and procedures relating to the clinical evaluation process, and train key personnel on them.
Function independently as a decision-maker on CER-related regulatory issues.

Requirements

What you’ll need

Bachelors Degree (± 16 years) Preferably in Life Sciences OR An equivalent combination of education and work experience
Minimum 5 years Medical devices, clinical research experience, or related industry
Prefer at least 3 years of related work experience in Quality role in medical device area and/or clinical trial environment
Prefer GCP audit experience
Fluent in English, any additional major language is a preferred asset
Excellent Communicator
Computer Literate.
Preferred Master’s Degree, RN, PharmD, PhD, or MD preferred.
Thorough understanding of the 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 international harmonized standards and guidelines related to medical devices, clinical studies, and quality systems.
Project management experience.
Excellent written, verbal and presentation skills in relevant areas of clinical/technical applications.
Strong command of medical and surgical terminology.
Demonstrated ability to identify and adapt to shifting priorities and competing demands.
Proven ability to deliver high-quality work within tight timelines.
Highly-developed interpersonal skills, and strong attention to detail.
Able to travel as needed.

Benefits

Comp & perks

No specified benefits mentioned

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Clinical Evaluation ReportsRegulatory responsesGCP auditProject managementMedical devicesClinical researchQuality systemsRoot cause analysisPreventive actionsCorrective actions

Soft Skills

Excellent communicatorWritten communicationVerbal communicationPresentation skillsInterpersonal skillsAttention to detailAdaptabilityTime managementDecision-makingTeam training

Certifications

Bachelor's DegreeMaster's DegreeRNPharmDPhDMD