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Head of Regulatory Machines, Water Systems & Digital

Head of Regulatory Machines, Water Systems & Digital

Fresenius Medical CareSchweinfurt, Bavaria, Germany
Vor 16 Tagen
Stellenbeschreibung

We are seeking a dynamic Head of Regulatory Machines, Water Systems & Digital (m / f / d) to lead our regulatory efforts for our cutting-edge active medical devices and water systems. As a pivotal leader, you will ensure compliance, manage product registrations, and support design and development initiatives globally.

Your tasks :

Overall Responsibilities :

  • Communication and collaboration with various departments and stakeholders.
  • Process optimization and monitoring of regulatory compliance.
  • Providing regulatory input and guidance for documentation and project teams.

Regulatory Documentation :

  • Creation and maintenance of regulatory product documentation.
  • Role of Product Center Manager in regulatory aspects.
  • Support for design projects and assessments.
  • Preparation of technical documents for clinical evaluations.

    • Product Registration :

  • Ensuring product availability in global markets.
  • Coordination of regulatory activities and submissions.
  • Registration of medical devices and production sites.
  • Support for pharmaceutical registrations and tender processes.

    • Change Management :

  • Participation in design change councils and approval processes.
  • Evaluation and implementation of product / process changes.

    • Creation / Review / Approval :

  • Declarations of conformity and creation of product center information.
  • Support for supplementary requests and marketing materials.

    • Your profile :

  • Bachelor's or master's degree in Engineering / Scientific discipline
  • 5+ years of experience in Regulatory or Quality Assurance (Medical Devices / Medicinal Products)
  • Expertise in global medical device regulations (e.g., MDD, MDR), risk management, and quality standards (e.g. ISO13485, ISO14971, EU Guidelines for GMP, IFDA 21 CDR §820.250, etc.)
  • Strong project management and communication skills
  • Excellent leadership, problem-solving, and decision-making abilities
  • High level of attention to detail with strong organizational skills
  • Ability to work collaboratively and manage cross-functional teams
  • Fluent English; proficiency with Office and QMS tools
  • Adaptability, resilience, and a proactive, solution-oriented approach

    • If you're passionate about regulatory compliance and ready to take on a leadership role, apply today!