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