Regulatory Compliance Expert for Medical Device Software

Vor 5 Tagen

Hamburg, Hamburg, Deutschland apoqlar Vollzeit

Transforming Healthcare with Innovative Technology

Apoqlar is a pioneering developer of medical mixed reality platforms, revolutionizing the healthcare industry with cutting-edge technology and innovative solutions. Our flagship product, VSI HoloMedicine, is a medically certified software platform that leverages the Microsoft HoloLens hardware to transform medical images, clinical workflows, and medical education into an interactive 3D mixed reality environment.

We are seeking an experienced Regulatory Compliance Expert to join our team in Hamburg, Germany (onsite/hybrid). As a key member of our Regulatory & Quality Management team, you will work closely with C-Level executives and engineering teams to ensure our medical device software meets regulatory requirements.

Responsibilities:

  • Develop and lead the regulatory strategy to ensure compliance with applicable laws, regulations, and standards, such as EU MDR 2017/745.
  • Maintain and optimize the current Quality Management System (QMS) and regulatory framework, focusing on processes like change control, design controls, verification and validation, and risk management.
  • Lead the regulatory approval processes globally and develop regulatory responses for questions from notified bodies, global regulators, and regulatory representatives.
  • Implement regulatory requirements and ensure compliance with current procedures, updating them as necessary.
  • Monitor new and revised regulatory requirements, standards, guidelines, and common specifications.
  • Handle serious incident and adverse event reporting, ensuring effective communication with Notified Bodies and Regulatory Authorities.
  • Act as the Person Responsible for Regulatory Compliance (PRRC).

Qualifications:

  • University degree in biomedical science, engineering, pharmacy, or any other applied natural sciences.
  • 7+ years of professional experience, including MDD/MDR and FDA submissions.
  • Practical knowledge of FDA 510K applications and proven track records of associated products.
  • Proficient knowledge of EU medical device regulations, QMS for medical devices, MDSAP, ISO 13485, IEC 62304, and ISO 14971.
  • Experience in communication with authorities and notified bodies.
  • In-depth knowledge of Software Lifecycle Processes, including 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 SCM.
  • Demonstrated ability to maintain and streamline QMS for seamless use across the organization.
  • Strong analytical skills to evaluate product compliance and interpret regulatory guidelines.
  • Fluency in English is required; German is a plus.

About Us:

  • We offer a chance to work with new and exciting technologies.
  • Opportunity to positively impact patients' lives worldwide.
  • Chance to shape and create an entirely new market in healthcare using medical mixed reality.
  • 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 executives.
  • High degree of ownership with opportunities to drive projects forward.
  • Competitive compensation structure and opportunities for growth within an advancing team.

Estimated Salary: €80,000 - €110,000 per year, depending on experience. Located in Hamburg, Germany.

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