MDR Consultant

About the role

MDR Compliance and Documentation Consultant supporting the creation, review, and maintenance of MDR technical documentation for medical devices, ensuring compliance with regulatory requirements and applicable harmonized standards.

Key responsibilities

• Support the creation, review, and maintenance of MDR technical documentation including clinical evaluation reports, risk management files, usability testing documentation, post-market surveillance reports, and design and manufacturing information
• Ensure all technical documents align with MDR requirements and applicable harmonized standards
• Ensure appropriate risk assessments are conducted and documented as per MDR requirements
• Provide expert advice on the preparation of technical documentation for regulatory submissions
• Provide consultancy on regulatory strategies for achieving MDR compliance
• Collaborate with internal and external stakeholders to ensure all product-related documents meet MDR requirements
• Review and assess technical documentation for compliance with the latest updates in MDR and ISO standards
• Assist in preparing for Notified Body audits and inspections, ensuring technical documentation is complete and compliant
• Work closely with regulatory affairs, quality assurance, clinical, and R&D teams to ensure all aspects of MDR technical documentation are accurate and up-to-date
• Support the development and implementation of post-market surveillance systems that comply with MDR

About you

• Bachelor's or Master degree in Biomedical sciences, Regulatory Affairs or related fields
• Previous experience in a similar regulatory affairs, compliance, or technical documentation role within MedTech, Pharma, or a related industry
• Hands-on experience in ensuring medical device products meet regulatory requirements, preparing technical documentation, risk management files, and CE marking for the European market
• Direct experience in creating, reviewing, and managing technical documentation including design dossiers, clinical evaluation reports, and post-market surveillance plans in compliance with MDR
• Strong familiarity with ISO 13485 and how it aligns with regulatory requirements for medical devices
• Experience working with ISO 14971 and understanding its application to the creation of risk management documentation for medical devices
• Good communications skills with professional level English required
• Teamworking skills, integrity, drive and organizational skills
• Able to handle documents attentively