Senior Medical Writer & Project Lead, Clinical Evaluation

Abbott; Saint Paul (MN); Vor Ort; USD 90.000 - 180.000; Vollzeit

Zusammenfassung

Abbott Laboratories, a global healthcare leader, seeks a Senior Medical Writer / Senior Project Manager, Clinical Evaluation to join Abbott Vascular on-site in Santa Clara, CA or Maple Grove, MN. You will combine scientific expertise, regulatory knowledge and project management to support EU CE marking submissions and ongoing clinical evaluations.

Ideal candidates have a science background, knowledge of EU MDR 2017/745, strong writing skills, and the ability to manage timelines and

Qualifikationen

• Scientific background in science, engineering, or medical fields; understanding of research design and statistics.
• Deep knowledge of EU MDR 2017/745, MDD, AIMDD, MEDDEV, and related medical device guidelines.
• Proven project management experience and ability to lead CER development and regulatory responses.
• Excellent written, verbal and presentation skills in clinical/technical applications.
• Ability to travel as needed (<10%).

Aufgaben

• Create and maintain Clinical Evaluation Plans, Clinical Evaluation Reports, and SSCPs.
• Identify, evaluate, and summarize clinical evidence from investigations, literature, and post-market data.
• Manage timelines of deliverables using project management tools.
• Communicate timelines and risks with cross-functional teams and writers.
• Interpret results for product applications by evaluating data and literature; stay current with clinical practice.
• Develop regulatory responses for Notified Body questions during submissions.
• Coordinate document exchange among internal and external stakeholders.
• Provide regulatory guidance on clinical data for new product development.
• Support audits and CAPA activities; participate in root cause analysis and quality metrics.
• Act as a independent decision-maker on CER-related regulatory issues.
• Execute projects within budgetary guidelines.

Kenntnisse

Scientific background

EU MDR knowledge

Project management

Academic/writing proficiency

Regulatory submissions

Cross-functional communication

Medical device experience

Clinical evaluation planning

CER writing and review

Regulatory strategy

Ausbildung

Bachelor’s degree

Master’s degree preferred

Jobbeschreibung

Abbott Laboratories, a global healthcare leader, seeks a Senior Medical Writer / Senior Project Manager, Clinical Evaluation to join Abbott Vascular on-site in Santa Clara, CA or Maple Grove, MN. You will combine scientific expertise, regulatory knowledge and project management to support EU CE marking submissions and ongoing clinical evaluations.

Ideal candidates have a science background, knowledge of EU MDR 2017/745, strong writing skills, and the ability to manage timelines and