This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
The Regulatory Affairs Specialist (Technical Writing) is primarily responsible for leading the creation and revision of clinical evaluation reports (CER) to support regulatory submissions. They also provide support with the generation of other technical documentation (e.g. FDA Q-submissions, PSURs).
Job Responsibility:
Primarily responsible for completing assigned clinical evaluation reports (CER) and other technical writing projects in a timely manner to meet business needs
Collaborate (write, review, and edit) with R&D, clinical, technical and regulatory teams on the creation of clinical evaluation reports, pre-submissions and other documentation intended for regulatory submissions
Conduct systematic literature searches for product-related data, including favourable and unfavourable data
Critically appraise and analyse clinical data from various sources (e.g. clinical investigations, post-market activities and vigilance systems)
Contribute to benefit-risk profile analysis for devices and show conformance to general safety and performance requirements
Conduct thorough quality control (QC) checks of documentation to ensure accuracy and consistency prior to approval
Contribute to discussions focused on gaps identified in available clinical data and support with any proposed strategies to address them
Ensure all technical writing is prepared and compliant with applicable requirements (e.g. EU MDR 2017/745, FDA Q-submission guidance, ISO standards, MDCG guidance)
Collaborate cross-functionally to ensure the accurate drafting and presentation of technical content within clinical evaluations and technical documentation
Provide technical writing support for global submission dossiers
Ensure conformance with applicable requirements in product development, support of claims, content labelling, and promotional materials
Provide Regulatory Affairs support during internal and external audits
Handle routine correspondence and enquiries with regulatory authorities and Notified Bodies as required, under the direct supervision of senior staff
Conduct gap assessments
report, assess and communicate applicable changes in requirements
Draft, update and maintain procedures relating to clinical evaluation and technical/regulatory writing
Mentorship of junior regulatory staff members, as required
Provide guidance, support and training to internal team members on clinical, technical and/or regulatory writing and applicable requirements
Support global submissions with clinical, technical and/or regulatory writing requests
Acts as a delegate for technical writing activities falling under the remit of the Senior Regulatory Affairs Specialist (Technical Writing), as needed
Requirements:
Bachelor’s Degree in a life science or equivalent
Minimum 5 Years’ experience of medical writing within the pharma or medical device industry
Experience of writing clinical evaluation reports and PSURs in line with the EU MDR 2017/745 and MDCG guidance documents
Experience of conducting systematic literature searches and reviews
Experience of writing regulatory submissions including dossiers for EU MDR submission and/or US FDA Q-submissions