25 km
headwaypersonal gmbh
Regulatory Affairs Project Manager (m/w/d) 14.11.2024 headwaypersonal gmbh Mannheim (DE)
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Regulatory Affairs Project Manager (m/w/d)

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headwaypersonal gmbh
Mannheim (DE)
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Regulatory Affairs Project Manager (m/w/d)
headwaypersonal gmbh
Mannheim (DE)
Aktualität: 14.11.2024

Anzeigeninhalt:

14.11.2024, headwaypersonal gmbh
Mannheim (DE)
Regulatory Affairs Project Manager (m/w/d)
Aufgaben:
- Leading and supporting regulatory strategies for global product submissions - 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
Qualifikationen:
- Bachelor's Degree in Life Sciences, Regulatory Affairs or a related field, alternatively completed vocational training with comparable experience in the regulatory field - Profound work experience in Regulatory Affairs; preferred in 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 & medical device - Strong organizational and communication skills - Ability to multitask and effectively manage multiple projects simultaneously - Self-motivated and capable of working independently in a self-management environment - Fluent in English (for international meetings), German skills are not necessarily required - Affinity for IT and good MS Office skills

Standorte