Senior Regulatory Affairs Specialist
Vor 2 Tagen
Solventum is a pioneering company that enables better, smarter, safer healthcare to improve lives. As a Senior Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with current national, European, and international regulatory and standard requirements for manufacturing, market access, and vigilance of medical devices.
Your 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 or scientific university degree or 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
- Hybrid work arrangement with remote work options and regular travel to Düsseldorf
- Competitive pay and benefits package
- Opportunities for professional growth and development
Solventum is an equal opportunity employer and values diversity. We are committed to maintaining the highest standards of integrity and professionalism in our recruitment process. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply.
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