Senior Regulatory Affairs Specialist (Hybrid - Acton, MA)
Core
Lead regulatory affairs activities to support domestic and international registration 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
Deliverable
client delivery
Required skills
Regulatory submissions (510k, PMA, CE Marking), Labeling review, Clinical study support, Change management (ECOs), International market knowledge, FDA agency interaction
Preferred skills
RAC Certification, 21 CFR 820 knowledge, CMDR, ISO 13485, MDD, ECO review, Specification document review
Technologies
Word, Excel, PowerPoint, Visio, Project
Responsibilities
Support regulatory approval for medical devices in domestic and international markets; Provide support for product development, manufacturing, and clinical studies; Review labeling, promotional materials, and packaging for regulatory compliance; Prepare and submit documentation to FDA and international agencies; Evaluate and approve Engineering Change Orders (ECOs); Represent Regulatory Affairs in project teams and decision-making processes.
Seniority
Senior, hands-on IC