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 for respiratory, imaging, and cardiac safety solutions.
Role type
Director, Regulatory Affairs
Builds
compliant medical device products for global market access
Domain
Medical Devices / Regulatory Compliance
Deliverable
client delivery
Required skills
FDA 21 CFR 820, ISO 13485, MDR, 510(k) submissions, global regulatory strategy, audit management, SOP development, post-market surveillance
Preferred skills
GCP, clinical trial environments, respiratory/imaging/cardiac safety domain knowledge
Technologies
None
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; 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