Senior Regulatory Affairs Specialist
Core
Develop regulatory strategies and prepare global submissions for implantable/active implantable medical devices to ensure compliance throughout the product lifecycle.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory strategies, global submissions (FDA, EU MDR), and product integration documentation for urology devices.
Domain
Medical Devices / Urology / Regulatory Affairs
Required skills
Regulatory strategy development, global submission preparation, FDA/EU regulation knowledge, design controls, cross-functional collaboration, technical writing, project management
Preferred skills
PMA/510(k) submission experience, clinical trial regulation knowledge, independent work, Microsoft Office proficiency
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Provide technical guidance and mentoring to team members; act as company representative with device reviewers; develop and implement regulatory strategies; lead regulatory aspects of product integration; review and approve design/manufacturing changes; prepare and submit global regulatory applications; review labeling and advertising for compliance; support special projects like sterilization processes.
Seniority
Senior, hands-on IC (via careerplan.io/jobs/563602813084320-senior-regulatory-affairs-specialist-at-bostonscientific)