Medical Device Compliance Specialist
vor 4 Wochen
Solventum is a leading company in the healthcare industry, and we are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with national, European, and international regulatory requirements for medical devices.
Key Responsibilities:
- Develop and implement international regulatory strategies for medical devices
- Ensure compliance with current national, European, and international regulatory and standard requirements for manufacturing, market access, and vigilance of medical devices
- 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
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:
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Collaborative and dynamic work environment
Solventum is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community.
Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
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