Regulatory Affairs Lead

Our Client

Our Client is a well-established a medical software company that uses virtual and mixed reality (VR/MR) to improve healthcare, they allow healthcare professionals to interact with 3D anatomical models, medical imaging, and simulated clinical scenarios.

Job Description

• Develop and lead the regulatory strategy to ensure compliance with applicable laws, regulations and ensure a fast and efficient certification of new product developments.
• Maintain and optimize the current QMS and RA framework, focusing on specific processes such as change control, design controls, verification and validation, and risk management.
• Lead the regulatory approval processes globally.
• Lead the development of regulatory responses for questions from notified bodies, global regulators and regulatory representatives upon review of submissions in relation to the technical dossier.
• Implement regulatory requirements in accordance with EU MDR 2017/745.
• Lead risk management activities and work closely with the risk management team through the life cycle of medical device software.
• Participate in and support external/internal audits and responses to audit findings as appropriate.
• Ensure compliance with the current regulatory procedures and update the procedures when new regulatory requirements are determined.
• Monitor the new/revised applicable regulatory requirements, standards, guidance, and common specifications.
• Handle serious incident and adverse event reporting.
• Ensure that the communication with Notified Bodies and Regulatory Authorities is effective and that all the required information is provided.
• Ensure that marketing communication is according to regulatory requirements.
• Ensure that regulatory and statutory requirements are fully met across the whole organization.
• Ensure the promotion of awareness of applicable regulatory requirements throughout the organization.
• Act as appointed Person Responsible for Regulatory Compliance (PRRC).

Requirements

• Bachelor Degree in Biomedical Science, Engineering, Pharmacy is preferred.
• Minimum 8 years of professional experience including MDD/MDR and FDA submissions.
• Proficient practical FDA 510K application knowledge and a proven track record of associated products.
• Proficient knowledge of EU medical device regulations and Quality Management Systems for medical devices.
• Knowledge of MDSAP, ISO 13485, IEC 62304 and ISO 14971.
• Experience in communication with authorities and notified bodies.
• In-depth knowledge of Software Lifecycle Processes, including expertise in implementing the requirements of the IEC 62304 standard and AAMI TIR45 guidance (agile).
• Extensive experience in Software as a Medical Device (SaMD), covering design controls, risk management, verification and validation, SOUP (Software of Unknown Provenance), and Software Configuration Management (SCM).
• Demonstrated ability to maintain and streamline QMS for seamless use across the organization, ensuring a sustainable and compliant system.
• Experience in communication with healthcare professionals.
• Strong analytical skills to evaluate product compliance and interpret regulatory guidelines.
• Ability to collaborate effectively with internal specialists and other external consultants (if required), ensuring alignment and cooperation.
• Experience in External and Internal Audits.