Senior Regulatory Affairs Specialist

Vor 2 Tagen

Neuss, Nordrhein-Westfalen, Deutschland Solventum Vollzeit

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 Description

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.

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 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
  • 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.

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