Regulatory Affairs Specialist II
Core
Provide regulatory support for submissions and compliance throughout the product development process for urology medical devices.
Role type
Senior Regulatory Affairs Specialist
Builds
Global regulatory applications and compliance strategies for new and modified medical devices
Domain
Medical Devices / Urology / Regulatory Affairs
Required skills
510(k) submissions, EU MDR, international regulatory registrations, FDA regulations, EU regulations, global regulatory standards, clinical trial regulations, design controls, quality system regulations
Preferred skills
Capital equipment support, medical electrical equipment support, single-use disposable device support, contract-manufactured product support, OEM product support, project management, Microsoft Office proficiency, technical writing
Technologies
Microsoft Office
Responsibilities
Provide technical guidance and regulatory training to teams; Develop and implement regulatory strategies for new devices and OEM partnerships; Serve as liaison for new business partners regarding product registrations; Coordinate team inputs for submissions; Prepare and submit global regulatory applications; Review and approve product and manufacturing changes; Support quality initiatives; Develop departmental policies; Review device labeling and advertising for compliance.