Regulatory Affairs CoordinatorMichael Page

Our client is a reference in the medical technology sector

• Support team members in creating CE Mark submissions and change notifications to our Notified Body (NB), including responding to regulatory inquiries
• Aid in the completion and upkeep of Technical Documentation for CE Mark, following regulatory requirements and best practices
• Stay informed of regulatory and standards changes, assisting in updating company policies and procedures to maintain compliance
• Provide regulatory support to cross-functional teams by interpreting regulatory requirements into actionable plans
• Participate in process improvement projects to increase the efficiency and effectiveness of regulatory procedures
• Assist in addressing regulatory questions from internal stakeholders such as Customer Service,
• Contracts/Tenders, Sales, and Marketing, providing clear and accurate regulatory guidance
• Support the Regulatory Affairs team by managing administrative duties related to regulatory submissions, including coordinating the signing of documents, maintaining records, and ensuring that all regulatory documents are properly archived and accessible
• Support in implementing and maintaining the Quality Management System, such as CAPA, Management Review, and audits
• Participate in internal/external audits and inspections, ensuring that company procedures, processes, and documentation meet the requirements of the Quality Management System, ISO 13485, and other applicable regulations
• Offer regulatory support to other departments such as R&D, engineering, and clinical affairs as needed

• 1-3 years of experience in regulatory affairs and/or quality compliance within the medical device sector, focusing on adherence to EU regulations
• A Bachelor's degree in Engineering, Medical Technology, or a closely related field, or equivalent practical experience in a similar role
• Basic understanding of global medical device regulations, including ISO 13485, the European Medical Device Regulation (2017/745/EU)
• Familiarity with EU submissions for new products and sustaining activities
• Strong organizational and planning skills, with a proactive approach to problem-solving
• Effective interpersonal abilities, capable of working collaboratively within international teams and across departments
• Fluent in English, with a minimum of C1 level proficiency for clear and effective communication

Early-stage knowledge of US FDA 21 CFR 820.30 and 510(k) submissions is a plus.