Regulatory Affairs Specialist

Requirements

• Previous experience in Regulatory Affairs, regulatory documentation, document control, quality systems, or a similar regulated administrative function
• Experience preparing, editing, formatting, reviewing, or maintaining controlled documentation
• Familiarity with electronic document management systems, regulatory information systems, or Quality Management Systems
• Strong organizational skills, with the ability to manage multiple activities, maintain trackers, and meet deadlines
• Excellent attention to detail and a commitment to documentation accuracy, consistency, and compliance
• Strong written communication skills and the ability to collaborate with stakeholders across functions and regions
• Good working knowledge of Microsoft Office applications, particularly Word and Excel
• A proactive, structured approach to problem-solving, follow-up, and process improvement

Nice to have:

• Previous experience within the medical device or wider MedTech industry
• Exposure to regulatory submissions, product labelling, market approvals, or post-market regulatory changes
• Familiarity with medical device regulatory frameworks, including the EU Medical Device Regulation (MDR)
• Experience with systems such as QUMAS, Agile, or MDRIM, or comparable regulatory and quality management platforms
• Experience supporting global or regional Regulatory Affairs teams in an international organization
• Knowledge of document publishing, submission tracking, regulatory metrics, or document lifecycle management
• Experience coordinating document legalisation or apostille processes

Benefits

• Opportunity to work within a globally established medical technology organization
• Exposure to international Regulatory Affairs operations and product lifecycle activities
• Experience supporting regulatory documentation and approvals across multiple markets
• Collaboration with experienced regulatory and quality professionals

Important Details

• Contract: 12-month fixed-term, with the possibility of extension
• Start date: Ideally December

About the Company

Our client is a globally recognized medical technology business operating across several major healthcare markets. The organization develops and delivers technologies, medical devices, and solutions designed to improve patient outcomes, support healthcare professionals, and address complex clinical needs. With an established international presence and a broad portfolio of healthcare technologies, the business operates within a highly regulated industry where product safety, quality, regulatory compliance, and reliable documentation are essential. Its products and services support healthcare professionals and healthcare systems in delivering effective treatment and care to patients worldwide.

Headquarters

European Union

Open jobs

57

Website

set.kellyservices.us