Senior Regulatory Affairs Manager (m/w/d)

Key Responsibilities

• Leading and supporting regulatory strategies for global IVD/MD instruments & software submissions especially in the cross customer area laboratory automation environment
• Ensuring compliance with international regulatory requirements and standards
• Collaborating with cross-functional teams, including R&D, Quality, and Clinical, to drive regulatory initiatives
• Providing regulatory guidance to support product development and lifecycle management
• Staying abreast of evolving regulatory trends and updates, and implementing best practices

Requirements

• Bachelor’s Degree in Life Sciences, Regulatory Affairs, or a related field
• 5 to 10 years of experience in Regulatory Affairs (Regulatory, R&D, Quality and/or Clinical), with some experience in healthcare regulatory affairs
• In-depth knowledge of global regulatory requirements, guidelines, and procedures especially for IVD instruments & software
• Strong organizational and communication skills
• The ability to multitask and effectively manage multiple projects simultaneously
• A self-motivated and capable of working independently in a self-management environment
• Experience in IVD instrument and/or software development ideally in the Laboratory Automation space

Benefits

• Langzeitkonto (bei unbefristetem Vertrag)
• Vorsorgeplan 2007
• Work-Life-Balance
• Sprachkurse, Risikoabsicherung, Kinderbetreuungsplätze, Kinderbetreuungszuschuss und interne Weiterbildungsmöglichkeiten

Pay

For this position, the main location is Mannheim. For information on other locations where the position may also be available, please refer to the application process.

Schedule

N/A