Regulatory Affairs Specialist - Medizintechnik & Diagnostik (Regulatory Affairs Manager)

Your Tasks

Do you want to reach the next level in your career? At Brunel, you have the opportunity to continuously develop yourself with well-known clients. Take the decisive step in your career today and apply to us!

• Management of regulatory activities for international markets
• Coordination of cross-departmental approval projects
• Support in the development and implementation of global registration strategies
• Ensuring the timely creation of regulatory documentation
• Assessment of product changes with regard to regulatory requirements
• Collaboration with international teams, authorities, and external partners
• Accompanying the entire product lifecycle from a regulatory perspective
• Analysis of new regulations and derivation of suitable measures
• Support with software and medical device approvals
• Optimization of existing processes in the regulatory environment
• Communication of regulatory requirements to various specialist departments

Your Qualifications

• Completed studies in the field of Life Sciences, Biology, Medizintechnik, Pharmacy, or comparable
• Professional experience in the field of Regulatory Affairs, Quality Management, or Medical Devices
• Good knowledge of European medical device regulations (MDR / IVDR)
• Experience in the coordination of complex projects and interfaces
• Very good English skills in speaking and writing
• Structured, independent, and solution-oriented way of working
• Strong communication skills as well as enjoyment of international cooperation

Your Benefits

Round tables with the local Brunel teams, as well as regular feedback discussions about your challenges and perspectives with your Account Manager. We offer you a corporate culture characterized by the diversity of our employees and mutual appreciation - between employees and at all corporate levels. In addition to varied tasks, you will be optimally supported through individual further education and training and prepared for future projects. Permanent employment contracts, 30 days of vacation, working time account regulations, as well as company, employer-funded pension schemes are a matter of course for us.

What Brunel Stands For

Working at Brunel means: attractive work tasks, extraordinary career perspectives, the security of an expanding engineering service provider, and the full diversity of engineering and IT. In the DACH-CZ region alone, we have 45 locations and development centers with accredited testing laboratories, and over 100 locations worldwide with more than 12,000 employees in over 40 countries. More than 45 years of international success and over 25 years in Germany. Stagnation means regression - with Brunel, you can make a difference!