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

Regulatory Affairs Expert