Associate Director Regulatory Affairs – Vascular (on-site)
Core
Sets strategy and directs preparation of regulatory submissions to obtain timely approval for vascular medical devices and software.
Role type
Associate Director, Regulatory Affairs (Manager level)
Builds
Regulatory submissions for drug-eluting stents, bare metal stents, guide wires, catheters, and software
Domain
Medical devices / Vascular / Regulatory Affairs
Required skills
Regulatory strategy, FDA compliance, 510k/PMA submissions, IEC standards, cybersecurity, AI regulations, staff management, stakeholder communication
Preferred skills
RAC certification, PCCP knowledge, hardware/software device experience, change control planning
Technologies
IEC 60601-1, FDA systems, QMS, EMS
Responsibilities
Directs staff in implementing regulatory strategy, consults senior management on approval strategies, maintains expert knowledge of laws and regulations, resolves regulatory problems, hires and retains staff, ensures compliance with FDA and international regulations
Seniority
Senior, hands-on IC with management responsibilities
