Regulatory Affairs and Quality Management Lead

vor 2 Wochen

Hamburg, Hamburg, Deutschland apoqlar Vollzeit
Join Our Team as a Regulatory Affairs and Quality Management Lead

At apoQlar, we're revolutionizing the healthcare industry with cutting-edge medical mixed reality technology. As a Regulatory Affairs and Quality Management Lead, you'll play a crucial role in ensuring our platform meets regulatory and statutory requirements.

About the Role:

  • Develop and lead the regulatory strategy to ensure compliance with applicable laws and regulations.
  • Maintain and optimize the current QMS and RA framework, focusing on specific processes such as change control, design controls, verification and validation, and risk management.
  • 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 through the life cycle of medical device software.
  • Participate in and support external/internal audits and responses to audit findings as appropriate.
  • Ensure compliance with the current regulatory procedures and update the procedures when new regulatory requirements are determined.
  • Monitor the new/revised applicable regulatory requirements, standards, guidance, and common specifications.
  • Handle serious incident and adverse event reporting.
  • Ensure that the communication with Notified Bodies and Regulatory Authorities is effective and that all the required information is provided.
  • Ensure that marketing communication is according to regulatory requirements.
  • Ensure that regulatory and statutory requirements are fully met across the whole organization.
  • Ensure the promotion of awareness of applicable regulatory requirements throughout the organization.
  • Act as appointed Person Responsible for Regulatory Compliance (PRRC).

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 14971.
  • 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 (agile).
  • Extensive experience in Software as a Medical Device (SaMD), covering design controls, risk management, verification and validation, SOUP (Software of Unknown Provenance), and Software Configuration Management (SCM).
  • Demonstrated ability to maintain and streamline QMS for seamless use across the organization, ensuring a sustainable and compliant system.
  • 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 (if required), ensuring alignment and cooperation.
  • 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 not just shape but also create an entirely new market in healthcare using medical mixed reality.
  • Work alongside a multicultural and international team – over 10 countries represented in our office.
  • A flat hierarchy with direct access to the founding team and C-Level.
  • High degree of ownership with the opportunity to drive projects forward on your own or with a team.
  • Competitive compensation structure and ability to grow quickly within an advancing team.

We're looking for a motivated and enthusiastic individual to join our team in Hamburg (onsite/hybrid) to expand our Regulatory & Quality Management team. If you're interested in helping us shape an entirely new market in healthcare and advancing next-generation medical technology, we look forward to hearing from you.

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