Job Description

An exciting opportunity has arisen for a Senior Regulatory Affairs Specialist to join Arjo at our head office in Houghton Regis to provide accountability and responsibility for the international registrations for Arjo products within a designated region.

Key duties include:

• Prepare product registration documentation for new and amended product licences for medical devices
• Perform impact assessments on product design, engineering change and management system planning process outputs and updated standards and regulations and prepare action plans to mitigate identified compliance and business risks
• Communicate progress of registrations with internal and external stakeholders
• Liaise with international affiliates, distributors and competent authorities to ensure timely licence approvals
• Record 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 internal auditor to established processes and external standards and regulations

Required Knowledge, Skills, and Abilities

BA or BS Degree is the minimum requirement with a major in a scientific discipline Considerable regulatory experience in the medical device industry and experience in Quality Assurance/Regulatory Affairs desirable Working knowledge of global medical device regulations Must be able to synthesize technical and clinical information to write clear, understandable licence application documents Must be able to render clear and accurate judgements Ability to work well in a cross-functional team Computer knowledge in Microsoft Word, Excel, Access etc Excellent written and verbal communication skills Intercultural skills Ability to work independently in a well-structured and systematic manner