Senior Regulatory Affairs Specialist
Vor 2 Tagen
Job Title: Senior Regulatory Affairs Specialist
About Solventum
Solventum 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 Summary
We are 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 managing compliance projects, developing and implementing international regulatory strategies for medical devices, and ensuring compliance with current national, European, and international regulatory and standard requirements.
Key Responsibilities
- Manage compliance projects and develop international regulatory strategies for medical devices
- Ensure compliance with current national, European, and international regulatory and standard 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
- Communicate with authorities, notified bodies, etc.
Requirements
- Engineering/scientific university degree or a comparable qualified education
- Experience in regulatory affairs and with 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
What We Offer
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.
How to Apply
To apply for this position, please submit your resume and cover letter through our website. We look forward to hearing from you
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