Director, Regulatory Affairs (f/m/d)
Core
Lead global regulatory activities to ensure compliance with FDA 21 CFR 820, ISO 13485, and international medical device regulations, acting as Person Responsible for Regulatory Compliance (PRRC).
Role type
Director, Regulatory Affairs
Builds
compliant medical device products for global markets
Domain
Medical Devices / Regulatory Affairs
Required skills
FDA regulations, ISO standards, global medical device requirements, 510(k) submissions, MDR, audit management, team leadership, SOP development, post-market surveillance
Preferred skills
Clinical trial environments, GCP
Technologies
FDA 21 CFR 820, ISO 13485
Responsibilities
Lead global regulatory activities, define and implement regulatory strategies, partner with cross-functional teams, establish trade compliance processes, guide and mentor engineering teams, assess regulatory impact of design changes, support regulatory submissions, review product labeling and documentation, participate in audits, oversee SOP development, support post-market surveillance
Seniority
Director, strategic leadership & team management