Aktuelle Jobs im Zusammenhang mit Regulatory Affairs and Quality Management Lead - Hamburg, Hamburg - apoqlar

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    vor 2 Wochen

    Hamburg, Hamburg, Deutschland apoqlar Vollzeit

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Regulatory Affairs and Quality Management Lead

vor 2 Monaten

Hamburg, Hamburg, Deutschland apoqlar Vollzeit
About the Role

We are seeking a highly skilled Regulatory Affairs and Quality Management Lead to join our team at apoQlar. As a key member of our Regulatory & Quality Management team, you will play a leading role in ensuring our medical mixed reality platform is in compliance with regulatory and statutory requirements.

Key Responsibilities
  • Develop and lead the regulatory strategy to ensure compliance with applicable laws and regulations.
  • Maintain and optimize the current Quality Management System (QMS) and Regulatory Affairs (RA) framework.
  • Lead the regulatory approval processes globally.
  • Implement regulatory requirements in accordance with EU MDR 2017/745.
  • Lead risk management activities and work closely with the risk management team.
  • Participate in and support external/internal audits and responses to audit findings.
  • Ensure compliance with current regulatory procedures and update procedures as needed.
  • Monitor new/revised applicable regulatory requirements, standards, guidance, and common specifications.
  • Handle serious incident and adverse event reporting.
  • Ensure effective communication with Notified Bodies and Regulatory Authorities.
  • Ensure marketing communication is in accordance with regulatory requirements.
Requirements
  • University degree in biomedical science, engineering, pharmacy, or any other applied natural sciences.
  • 7+ years of professional experience including MDD/MDR and FDA submissions.
  • Proficient practical FDA 510K application knowledge and a proven track record of associated products.
  • Proficient knowledge of EU medical device regulations and Quality Management Systems for medical devices.
  • Knowledge of MDSAP, ISO 13485, IEC 62304, and ISO.
  • Experience in communication with authorities and notified bodies.
  • In-depth knowledge of Software Lifecycle Processes, including expertise in implementing the requirements of the IEC 62304 standard and AAMI TIR45 guidance.
  • Extensive experience in Software as a Medical Device (SaMD), covering design controls, risk management, verification and validation, SOUP, and Software Configuration Management (SCM).
  • Demonstrated ability to maintain and streamline QMS for seamless use across the organization.
  • Experience in communication with healthcare professionals.
  • Strong analytical skills to evaluate product compliance and interpret regulatory guidelines.
  • Ability to collaborate effectively with internal specialists and other external consultants.
  • Experience in external and internal audits.
  • Fluency in English is a requirement, German is a huge plus.
Why apoQlar?
  • Chance to work with new and exciting technologies.
  • Opportunity to positively impact the lives of patients, students, and surgeons around the world.
  • Chance to shape and create an entirely new market in healthcare using medical mixed reality.
  • Work alongside a multicultural and international team.
  • A flat hierarchy with direct access to the founding team and C-Level.
  • High degree of ownership with the opportunity to drive projects forward.
  • Competitive compensation structure and ability to grow quickly within an advancing team.