Senior Regulatory Affairs Specialist - Medical Device

Responsibilities:
• Implement day to day regulatory activities to ensure continual regulatory compliance with FDA, Notified Body and Health Canada requirements.
• Prepare, review and submit domestic and international paper-based and electronic regulatory submissions, including 510(k) premarket notification, medical device license application to Health Canada.
• Monitor, review and interpret new or changed regulatory.
• Review and approve product labeling, including marketing literature/collateral, as needed, to assure compliance with approved indications and applicable regional regulations.
• Implement regulatory strategies and regulatory project timelines that ensure continued compliance with domestic and international regulations.

Requirements:
• Master of Science degree in Life Sciences, or Engineering.
• 10+ years Regulatory Affairs Class III medical device experience.
• In-depth knowledge of FDA regulations, including FDA Quality System Regulation (QSR), and EU Council Directive 93/42/EEC (MDD).
• Hand-on 510(k) submission, CE mark application (Class IIa, IIb and III), and Medical Device License Application (Health Canada)