About this role
General:
• Works independently on tasks and projects within the scope of Product Regulatory Affairs, ensuring compliance with applicable regulations and standards. • Establishes and manages priorities effectively to meet deadlines and align with business and regulatory requirements. • Exercises sound judgment makes informed decisions within their area of responsibility and assumes accountability for outcomes. • Provides technical guidance and support to Junior Regulatory Affairs Experts, fostering their development and ensuring high-quality deliverables.
Your responsibilities:
• Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling • Strong knowledge of global medical device regulations, including MDR 2017/745, FDA SaMD Guidance, IMDRF SaMD Principles, NMPA, and requirements for cloud‑based medical software. • Ensure compliance with regulatory standards and testing requirements throughout product design and development • Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities • Ensure global regulatory product availability aligned with commercial strategy by managing registrations, renewals, and submissions • Coordinate regulatory product strategies • Drive regulatory assessments for product and process changes, including software updates, patches, cloud‑infrastructure changes • Lead regulatory aspects of product and process changes, including regulatory documentation.
Your profile:
• Master’s degree in Technical, Engineering, or Scientific fields • Minimum of 8-10 years in Regulatory Affairs or Quality Assurance in Medical Devices or Medicinal Products • Knowledge of development and manufacturing processes • Familiarity with quality and risk management standards, including ISO 13485, ISO 14971, IEC 62304 (Software Lifecycle), IEC 82304‑1 (Health Software), and IEC 81001‑5‑1 (Health Software Cybersecurity). • Strong knowledge of global medical device regulations, including MDR 2017/745, FDA SaMD Guidance, IMDRF SaMD Principles, NMPA, and requirements for cloud‑based medical software. • Experience with cybersecurity, data protection (GDPR), and cloud compliance frameworks relevant to medical devices. • Lead regulatory strategy for cloud‑hosted medical software, including data protection, cybersecurity, interoperability, and cross‑border data transfer requirements. • Strong communication and interpersonal skills • Fluent in English, both written and spoken