Medical Device Registration Engineer简历模板

Systematically studied professional knowledge such as relevant regulations for medical devices, product design and development processes. Through participation in the school's medical device innovation practice projects, mastered the writing logic and skills of basic medical device registration and declaration documents.

• Responsible for the domestic registration and declaration of the company's Class III medical device products. Combed product technical documents and closely communicated with the R & D team to ensure that the declaration materials meet the requirements of regulations such as the "Regulations on the Supervision and Administration of Medical Devices".
• Successfully led the registration and declaration of [Product Name]. It only took [X] months from start to certification, which was [X]% shorter than the industry average cycle, winning the opportunity for the product to quickly go on the market and seize the market.
• Continuously tracked the dynamics of medical device regulations, timely updated the company's product registration strategy, and established a complete registration document management system, covering [X] types of products and [X] documents, ensuring the traceability and compliance of documents.

• Led the registration team ([X] people) to be responsible for the registration affairs of the company's domestic and foreign medical device products. Formulated the annual registration plan and coordinated resources to promote projects.
• Led the completion of EU CE certification for [X] Class II medical device products. By optimizing the certification process, reduced the certification cost by [X]%.
• Built a good communication channel with regulatory agencies, organized [X] internal regulatory training sessions, trained [X] person - times, and improved the overall regulatory understanding and application ability of the team.

• As a core member, participated in the domestic registration project of [High - end Color Doppler Ultrasound Equipment], responsible for writing product technical requirements, reviewing clinical trial materials, etc.
• Conducted in - depth research on regulations such as "Medical Device Classification Catalog", accurately defined product classification, coordinated clinical institutions to complete [X] clinical trials, with a data integrity rate of [X]%.
• Followed up the registration review throughout the process. In response to the review opinions, quickly organized R & D, clinical and other departments for technical defense and data supplementation. Finally, the product was successfully approved for listing, with sales of [X] billion yuan in the first year of listing.

• Led the EU CE certification project of [Cardiac Stent System], analyzed EU MDR regulatory requirements, and established a product conformity assessment plan.
• Organized the writing of CE technical documents ([X] ten thousand words), covering modules such as product design and development, production process control, and clinical evaluation. Passed the review of the EU notified body [Institution Name].
• During the project implementation, coordinated domestic and foreign teams to solve [X] technical problems, such as material biocompatibility verification. Finally, the product passed the certification at one time, laying the foundation for the company to expand the European market.