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Senior Manager Global Compliance

vor 2 Monaten


Barbaraviertel Neuss, Deutschland Solventum Vollzeit
Unlock Your Potential at Solventum

At Solventum, we're committed to creating breakthrough solutions that change patients' lives for the better. As a Senior Manager Global Compliance, you'll play a critical role in shaping our regulatory strategy and ensuring compliance with international standards.

Key Responsibilities:
  • Develop and implement international regulatory strategies for medical devices, ensuring compliance with current national, European, and international regulatory requirements.
  • Create and maintain regulatory documents for European and international product submissions, ensuring accuracy and adherence to regulatory standards.
  • Support and further develop the quality management system according to EN ISO 13485, EU MDR 2017/745, and MDSAP, ensuring seamless integration with our global operations.
  • Communicate effectively with authorities, notified bodies, and other stakeholders, ensuring timely and accurate responses to regulatory inquiries.
Requirements:
  • Engineering/scientific university degree (Dipl., Master, Bachelor) or a comparable qualified education.
  • Experience in regulatory affairs and quality management systems in the medical device or pharmaceutical industry.
  • Knowledge of medical device regulations EN ISO 13485, EU MDR 2017/745, MDSAP, US QSR, GMP, and other relevant standards.
  • Fluent German and English language skills, both written and verbal.
What We Offer:

As a Senior Manager Global Compliance at Solventum, you'll enjoy a competitive salary and benefits package, as well as opportunities for professional growth and development in a dynamic and innovative environment. We're committed to supporting your well-being and providing a work-life balance that suits your needs.

Please note that your application may not be considered if you don't provide your education and work history, either by uploading a resume or entering the information directly into the application fields.

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