Director, Regulatory Affairs (f/m/d)
Core
Lead global regulatory strategy and compliance for clinical trial technologies and medical devices to ensure market access and patient safety.
Role type
Director, Regulatory Affairs
Builds
Global regulatory compliance frameworks, product registrations, and submission strategies for medical devices.
Domain
Medical Devices / Clinical Trial Technologies
Deliverable
client delivery
Required skills
FDA regulations, ISO standards, global medical device requirements, 510(k) submissions, MDR, regulatory submissions, audit management, SOP development, post-market surveillance, PRRC responsibilities
Preferred skills
Clinical trial environments, GCP
Technologies
FDA 21 CFR 820, ISO 13485
Responsibilities
Lead global regulatory activities to ensure compliance with FDA 21 CFR 820, ISO 13485, and international medical and non-medical device regulations; Define and implement regulatory strategies across the full product lifecycle; Partner with Product Management, Logistics, and Engineering teams to ensure compliant product development and global market access; Establish and optimize global processes for trade compliance, import/export, and supply chain regulatory requirements; Guide and mentor a team of hardware and software development engineers; Assess regulatory impact of changes to design, materials, labeling, software, and suppliers; Support regulatory submissions, including FDA 510(k) filings and international product registrations; Review and approve product labeling, technical documentation, and marketing materials to ensure regulatory alignment; Participate in internal, external, and vendor audits and contribute to corrective and preventive action initiatives; Act as Person Responsible for Regulatory Compliance (PRRC) under MDR requirements; Oversee the development and maintenance of SOPs and work instructions aligned with global standards; Support post-market surveillance, vigilance reporting, and continuous improvement activities
Seniority
Director, strategic leadership & team management