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.