Senior Regulatory Affairs Specialist (Hybrid - Acton, MA)
Core
Lead regulatory affairs activities to support domestic and international registrations and submissions for medical devices.
Role type
Senior Regulatory Affairs Specialist
Builds
Regulatory submissions and compliance documentation for medical devices
Domain
Medical Devices / Regulatory Affairs
Required skills
Regulatory submissions (510k, PMA, CE Marking), FDA and international agency compliance, labeling and promotional material review, change control (ECOs), vendor documentation review, project documentation management
Preferred skills
RAC Certification, knowledge of 21 CFR 820, CMDR, ISO 13485, MDD, ECO review, requirements and specification document review
Technologies
Word, Excel, PowerPoint, Visio, Project
Responsibilities
Support regulatory approval of medical devices in domestic and international markets; Provide regulatory support for product development, manufacturing, and clinical studies; Compile and submit documentation for marketing initiatives; Review labeling, promotional materials, and packaging for regulatory impact; Represent Regulatory Affairs on project teams; Assist with pre-market and post-market filings; Prepare submissions and reports for FDA and international agencies; Review and approve project documentation such as specifications, procedures, and test protocols; Evaluate and communicate change assessments to ensure compliance.
Seniority
Senior, hands-on IC