Senior Regulatory Affairs Specialist
Vor 3 Tagen
Solventum is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Düsseldorf. 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 adherence to regulatory requirements
- Drive regulatory strategies during product development or product modification
- Create and maintain regulatory documents for European and international product submissions
- Support and develop the quality management system according to EN ISO 13485, EU MDR 2017/745, and MDSAP
- Engineering/scientific university degree or a comparable qualified education
- Experience in regulatory affairs and quality management systems in the medical device or pharmaceutical industry
- Ideal knowledge of 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
Solventum offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are an equal opportunity employer and value diversity at our company. If you are a motivated and experienced regulatory affairs professional looking for a new challenge, please submit your application.
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Senior Regulatory Affairs Specialist
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