Regulatory Affairs Specialist

The Role An exciting opportunity for a Regulatory Affairs Specialist to join the Malmo global QRC Product Registrations team, based in Komorniki, near Poznan, Poland. The role will be responsible for conducting international product registrations for all Arjo and OEM product portfolios and also supporting wider QRC projects and activities. Focus of the role will be to plan and execute regulatory strategies for the timely registration and approval of our products and also to ensure compliance with global and local country regulations and requirements. Prepares regulatory submissions for new and amended product licence applications for Class I, Im, and IIa medical devices. Communicate progress of registrations with internal stakeholders: Project Owners, Engineering, Technical Publications, SSUs, Commercial and Management as required. Liaise with international affiliates, SSUs, distributors and competent authorities to ensure timely licence approvals. Records registration activities on internal tracking databases. Prepare briefing summaries and training on regulations, processes and guidelines within area of responsibility. Assist in projects within the Regulatory Affairs function. Act as an internal auditor to established processes and external standards and regulations. Ensure and maintain up to date knowledge on international regulatory requirements within assigned scope, and effectively communicate requirements to project teams and management. Knowledge / Skills / Experience BA or BS degree with a major in a scientific discipline Regulatory experience in the medical device industry or experience in Quality Assurance or similar desirable Must be able to synthesise technical and clinical information to write clear, understandable licence application documents in English Must be able to render clear and accurate judgments and have decision making skills Ability to work well in cross-functional teams Excellent written and verbal communication skills Ability to work independently in a well-structured and systematic manner Personal Qualities Attention to Detail: Regulatory affairs specialists must meticulously review documents and ensure compliance with regulations Curiosity: Questioning interest around the regulatory industry, the whole product lifecycle and our QMS processes, is a valuable quality Analytical Thinking: They need to analyse complex regulations and apply them to specific situations Communication Skills: Effective communication with regulatory bodies and internal teams is crucial Problem-Solving: They must be adept at identifying issues and finding compliant solutions Conscientiousness: Being thorough and diligent in their work is essential Adaptability: The regulatory landscape can change frequently, so being adaptable is important Working well with cross-functional teams is often necessary to ensure compliance Commitment to Continuous Learning: Staying updated with the latest regulations and guidelines #J-18808-Ljbffr Arjo Italia S.p.A.