Beschreibung
Our client is a leading medical technology company and has been advancing surgical procedures globally. With extensive expertise in surgical technologies and orthopedic solutions, the company aims to elevate healthcare worldwide through innovative products and services.We are looking for a Neurovascular Specialist Lead for Clinical Evaluations and Notified Body Responses - a remote role open to candidates in EU or US Timezones.
Responsibilities:
Advise scientists and writers across the Cerenovus franchise on compiling and analyzing product safety data and collaborate on clinical evaluation strategies.
Provide strategic direction on Clinical Evaluation Data Route, including equivalency and vascular clinical condition strategies for new products.
Optimize and harmonize CER and SSCP processes in line with industry guidelines.
Develop materials, lead workshops, and provide training to ensure guideline implementation.
Lead interactions with the Notified Body, developing strategies for addressing clinical review questions related to endovascular stroke treatment.
Translate insights into valuable processes and solutions for Scientific Operations.
Qualifications:
Experience in setting up a strategy in the area of Clinical Trial/Revue
Master’s degree in Life Sciences, Engineering, or related field.
Neurovascular experience, especially in endovascular treatment of hemorrhagic and ischemic stroke.
Expertise in clinical trials, post-market follow-ups, and regulatory submissions.
Minimum 8 years' experience in a regulated environment, including 5 years in medical device writing and leadership.
Knowledge in quality, regulatory affairs, clinical trial design, and global management.
If you are interested in this assignment and have free resources for the specified period, I would be very pleased to receive your CV with details of your availability and conditions to:
You are also welcome to contact me in advance by telephone -