Abbott
Clinical Evaluation, Project Manager - Clinical Scientist
Abbott, Saint Paul, Minnesota, United States
Senior Project Manager, Clinical Evaluation
Senior Project Manager, Clinical Evaluation
role at
Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life‑changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Overview The Clinical Evaluation Project Manager supports Structural Heart Products by applying scientific and research methodology, medical device regulations and guidelines, and product knowledge. This role is key to Regulatory Affairs submissions for CE Marking of new devices and maintaining CE Mark for existing devices in accordance with European Commission Guidelines on Medical Devices, MEDDEV 2.7/1 Rev 4, and EU Regulation 2017/745.
The CER PM is a subject‑matter expert on guidelines and regulations for the clinical evaluation process and its documents (e.g., CEP, PMS/PMCF Plan, SSCP and PSUR, CER). Responsibilities include overseeing medical writers, coordinating cross‑functional teams, gathering data on safety and performance, contributing to risk assessment and management, and leading regulatory responses to Notified Body questions.
Main Responsibilities
Manage medical writers’ efforts in writing and editing scientific content of deliverables, and the timelines of these documents
Create, manage, or participate in timelines of deliverables using appropriate project management tools
Communicate timelines, project risks, and risk mitigation strategies with cross‑functional teams and medical writers
Interpret results in preparation for product applications by evaluating clinical, scientific and risk data and literature
Write and edit Clinical Evaluation Plans and Clinical Evaluation Reports and other CER deliverables as needed
Lead the development of regulatory responses for Notified Body questions upon review of submissions
Facilitate communication and exchange of documents between stakeholders, including internal personnel and external vendors such as CROs, medical writers and reviewers
Provide strategic guidance on regulatory requirements pertaining to clinical data and clinical evaluation to new product development and sustaining teams
Participate in and support audits and responses to audit findings, including root cause analysis, preventive or corrective actions, and effectiveness monitoring
Function independently as a decision‑maker on CER‑related regulatory issues and ensure deadlines are met
Execute projects within budgetary guidelines
Required Qualifications
Associate’s Degree (±13 years)
Minimum 7 years of related experience
Preferred Qualifications
Bachelor’s degree in life sciences (nursing, medicine, biomedical engineering)
Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4 and MDR submissions
3–5+ years of experience in clinical research, quality systems, or regulatory experience in medical devices
Understanding of regulations, standards and guidelines related to medical device clinical studies and quality systems (MDD 93/42/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485)
Effective written, verbal and presentation skills in technical/clinical applications
Strong command of medical and surgical terminology
Project management and/or management of people experience
Demonstrated ability to identify and adapt to shifting priorities and competing demands
Highly developed interpersonal skills, with strong attention to detail and accountability for ensuring deliverables are met on time
Post‑graduate degree (Masters or Doctorate) in life sciences preferred (nursing, medicine, biomedical engineering)
Experience in structural heart / structural intervention devices
Certifications such as RAC and PMP considered a plus
MD / PhD / RN / Pharm D with strong written skills
The base pay for this position is $75,300.00 – $150,700.00. In specific locations, the pay range may vary from the range posted.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Project Management and Information Technology
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role at
Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life‑changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Overview The Clinical Evaluation Project Manager supports Structural Heart Products by applying scientific and research methodology, medical device regulations and guidelines, and product knowledge. This role is key to Regulatory Affairs submissions for CE Marking of new devices and maintaining CE Mark for existing devices in accordance with European Commission Guidelines on Medical Devices, MEDDEV 2.7/1 Rev 4, and EU Regulation 2017/745.
The CER PM is a subject‑matter expert on guidelines and regulations for the clinical evaluation process and its documents (e.g., CEP, PMS/PMCF Plan, SSCP and PSUR, CER). Responsibilities include overseeing medical writers, coordinating cross‑functional teams, gathering data on safety and performance, contributing to risk assessment and management, and leading regulatory responses to Notified Body questions.
Main Responsibilities
Manage medical writers’ efforts in writing and editing scientific content of deliverables, and the timelines of these documents
Create, manage, or participate in timelines of deliverables using appropriate project management tools
Communicate timelines, project risks, and risk mitigation strategies with cross‑functional teams and medical writers
Interpret results in preparation for product applications by evaluating clinical, scientific and risk data and literature
Write and edit Clinical Evaluation Plans and Clinical Evaluation Reports and other CER deliverables as needed
Lead the development of regulatory responses for Notified Body questions upon review of submissions
Facilitate communication and exchange of documents between stakeholders, including internal personnel and external vendors such as CROs, medical writers and reviewers
Provide strategic guidance on regulatory requirements pertaining to clinical data and clinical evaluation to new product development and sustaining teams
Participate in and support audits and responses to audit findings, including root cause analysis, preventive or corrective actions, and effectiveness monitoring
Function independently as a decision‑maker on CER‑related regulatory issues and ensure deadlines are met
Execute projects within budgetary guidelines
Required Qualifications
Associate’s Degree (±13 years)
Minimum 7 years of related experience
Preferred Qualifications
Bachelor’s degree in life sciences (nursing, medicine, biomedical engineering)
Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4 and MDR submissions
3–5+ years of experience in clinical research, quality systems, or regulatory experience in medical devices
Understanding of regulations, standards and guidelines related to medical device clinical studies and quality systems (MDD 93/42/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485)
Effective written, verbal and presentation skills in technical/clinical applications
Strong command of medical and surgical terminology
Project management and/or management of people experience
Demonstrated ability to identify and adapt to shifting priorities and competing demands
Highly developed interpersonal skills, with strong attention to detail and accountability for ensuring deliverables are met on time
Post‑graduate degree (Masters or Doctorate) in life sciences preferred (nursing, medicine, biomedical engineering)
Experience in structural heart / structural intervention devices
Certifications such as RAC and PMP considered a plus
MD / PhD / RN / Pharm D with strong written skills
The base pay for this position is $75,300.00 – $150,700.00. In specific locations, the pay range may vary from the range posted.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Project Management and Information Technology
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