Senior Regulatory Affairs Specialist
vor 3 Stunden
Solventum is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with current national, European, and international regulatory and standard requirements for manufacturing, market access, and vigilance of medical devices.
Key Responsibilities:- Develop and implement international regulatory strategies for medical devices
- Manage compliance projects and ensure compliance with regulatory requirements
- Drive regulatory strategies during product development or product modification
- Create, develop, and maintain regulatory documents for European and international product submissions
- Support and further develop the quality management system according to EN ISO 13485, EU MDR 2017/745, and MDSAP
- Engineering/scientific university degree (Dipl., Master, Bachelor) or a comparable qualified education
- Experience in regulatory affairs and with quality management systems in the medical device or pharmaceutical industry
- Ideally, you have knowledge of the medical device regulations EN ISO 13485, EU MDR 2017/745, MDSAP, US QSR, GMP, etc
- Fluent German and English language skills, both written and verbal
- Ability to work in cross-functional and cross-cultural teams
- Good communication and decision-making skills
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Senior Regulatory Affairs Specialist
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Senior Regulatory Affairs Specialist
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Neuss, Nordrhein-Westfalen, Deutschland Solventum VollzeitJob Title: Senior Regulatory Affairs SpecialistAbout SolventumSolventum is a leading company in the healthcare industry, dedicated to creating innovative solutions that improve lives. As a new company with a long legacy of creating breakthrough solutions, we pioneer game-changing innovations at the intersection of health, material, and data science.Job...
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Neuss, Nordrhein-Westfalen, Deutschland Solventum VollzeitJob Title: Senior Regulatory Affairs SpecialistAbout SolventumSolventum is a leading company in the healthcare industry, dedicated to creating innovative solutions that improve lives. As a new company with a long legacy of creating breakthrough solutions, we pioneer game-changing innovations at the intersection of health, material, and data science.Job...
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