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Senior Regulatory Affairs Manager

vor 2 Monaten


Freiburg, Baden-Württemberg, Deutschland neuroloop GmbH Vollzeit
Job Description

We are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at neuroloop GmbH. As a key member of our regulatory affairs department, you will play a critical role in ensuring the compliance of our medical devices with international regulations.

Key Responsibilities
  • Prepare and compile regulatory submission dossiers for new medical device registrations and changes to existing products, in accordance with regulations.
  • Monitor new legislations, policies, standards and guidelines that affect the assigned product portfolio.
  • Conduct post-market surveillance and report adverse events / field safety corrective actions to the authorities.
  • Support currently marketed products, e.g., review engineering changes, product labeling and promotional materials.
Requirements
  • Degree in natural sciences, technology, engineering, medicine or a comparable degree or have acquired a comparable qualification.
  • Several years of relevant professional experience in the field of medical device regulation.
  • Extensive knowledge of regulatory affairs with a focus on international product approvals.
  • In-depth knowledge of European and international medical device regulations, directives and standards.
  • Good skills in written and spoken German and English.
Personal Qualities
  • Collaboration with cross-functional teams to collect necessary information.
  • Enthusiasm for mastering challenges in a team and showing the necessary stamina when things get difficult.
  • Positive attitude and communication in an open and direct manner.
  • Impressive performance and achievement of outstanding results.
  • Constructive interaction, taking responsibility and sharing knowledge actively.
What We Offer

Become part of a corporate culture that fosters accountability, diversity and trust within a dynamic family-owned company. Work in a start-up environment with short lines of communication and quick decision-making, but with the opportunities and security of a global healthcare leader. Take over an exciting role in a company that is working to develop the next generation of active medical implants. You can expect a variety of tasks and challenges that will allow you to grow.

Benefits

  • A family-friendly atmosphere with flexible working hours.
  • Performance-related remuneration.
  • A brand new, modern office optimized for concentration and collaboration and generous social areas and creativity zones.
  • High quality life in one of Germany's most attractive cities.