Regulatory Affairs Expert

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