Informationen zur Anzeige:
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