🚀 Regulatory Affairs Manager (m/f/d) (ID: 21877)

Human Resources Recruiting Specialist & Team Coordinator

• Authorisations & Dossiers: Preparation, submission, and maintenance of regulatory dossiers
• Authority Communication: Preparation and conduct of meetings with regulatory authorities
• Product Lifecycle: Renewals, variations, and change management
• Project Management: Coordination of regulatory projects and external partners
• Strategies: Development of regulatory strategies and support of project teams
• Systems & Data: Maintenance of databases and evaluation of new IT tools
• Product Information & Due Diligence: Preparation of product texts, translations, and regulatory due diligence

Ihr Profil:

• Natural scientific or medical device engineering background (pharmacist, biologist, chemist etc.), approbation, diploma, master degree or PhD
• Approx. 3-6 years of experience in international regulatory affairs field for medical devices
• Experience in registration of high risk devices (class III)
• Experience in medical device registrations in international markets
• High affinity for IT tools, MS Office skills
• Business fluent English
• Training on the job und Sprachkurse

Seniority level

• Mid-Senior level

Employment type

• Full-time

Industries

• Motor Vehicle Manufacturing

Location: Frankfurt am Main, Hesse, Germany