EU MDR Engineer MDR regulations
Synaptein SolutionsContractor Full day
Our services help organizations use data and analytics to create new business models and revenue streams – all while ensuring security, quality and regulatory compliance of data. Underpinned by technologies such as cloud, Internet of Things (IoT), Artificial Intelligence (AI), Machine Learning (ML) and advanced analytics, our solutions help enhance decision making while enabling augmented intelligence and process automation.
Role:- EU MDR Engineer-MDR regulations
Location:- West Chester, PA
Duration: 12 Month+ Contract
Rate: $35 to $38/hr W2
Create & develop technical documentation as per EU MDR requirements
Review & map design control documents in technical documentation
develop applicable standards checklist for NeuWave products
Review with cross functional team
Support NeuWave Regulatory director on regulatory work
Review deliverables against EU-MDR requirements and Ethicon specifications.
Closely working with R&D and QA SME in aligning gaps, creating detailed Techfile remediation plan for each product and monitoring remediation progress
Communicate with R&D/QA on techfiles related requirements and remediation activities.
Support on Preparing and filing Declarations of Conformity
Reviewing existing techfiles for extension submissions and creating internal memos before signing techfiles for extension
Conducting independent research, studies, reviews and analysis to supporting for regulatory projects.
Need to be expert in these skills:
Regulatory medical writing
Medical device experience at least 4 years
Good understanding of MDR regulations
Good project management skills
Preferable to have good clinical research experienc
All your information will be kept confidential according to EEO guidelines.