Regulatory Affairs Professional

vor 1 Tag

Lausanne, Waadt, Schweiz ONWARD (GTX Medical) Vollzeit

About the Position

We are seeking a highly skilled Regulatory Affairs Professional to join our team at ONWARD (GTX Medical). In this role, you will play a critical part in ensuring the production and delivery of innovative therapies for individuals with spinal cord injuries.

As a Regulatory Affairs Professional, your primary focus will be on upholding the highest standards of quality and compliance in the development of ONWARD medical systems. These include Class III medical systems, which encompass both implantable and external medical device components, as well as Software as a Medical Device (SaMD).

Your responsibilities will include establishing and implementing compliant regulatory processes that oversee the design, development, validation, and clinical application of these advanced medical systems.

  • Serve as the Regulatory representative for the Design Control process in Software development, ensuring consistent application and maintenance.
  • Provide expert regulatory support for Software design and development, including safety classification, risk assessment, testing, verification, validation, configuration management, and software releases.
  • Maintain a compliant Bug Tracking System, supporting anomaly management, problem resolution, and evaluations while ensuring effective follow-up.
  • Guide Software Teams in adhering to industry standards and regulatory guidelines, offering essential training to enhance compliance awareness.
  • Oversee the implementation, maintenance, and continuous improvement of ONWARD's regulatory processes, ensuring alignment with evolving industry standards and regulatory requirements.
  • Manage Software supplier quality, including supplier certifications and audits, to maintain high compliance standards.
  • Support regulatory compliance efforts related to Software, Cybersecurity, usability, and human factors in accordance with IEC 62366-1 and other relevant standards for Active Implantable Devices and Software as Medical Devices.
  • Act as the Regulatory representative for overall Design Control, covering Hardware and System Design Reviews, Design Verification, and Design Validation.
  • Oversee Change Control and Problem Resolution processes, including Non-Conformities, Device Deficiencies, and CAPA (Corrective and Preventive Actions).
  • Lead structural improvements in the Quality Management System (QMS) to enhance efficiency and compliance.
  • Drive continuous improvement in Quality System processes, fostering a culture of excellence, compliance, and innovation.

About You

We are looking for a highly motivated and experienced individual with a strong background in regulatory affairs and quality assurance. The ideal candidate will have a Master's degree in Life Sciences, Engineering, or a related field and 3 to 5 years of relevant industry experience in medical devices, preferably Class III (MDR) or Active Implantable Medical Devices (AIMD).

The successful candidate will have expertise in FDA software validation, Cybersecurity, and IEC 62304 Software Lifecycle process standards, as well as strong knowledge of ISO 14971 (Risk Management for Medical Devices). Experience applying usability engineering principles in accordance with IEC 62366-1 is also highly desirable.

Additional requirements include proficiency in medical device documentation and compliance with industry standards and guidelines, hands-on experience with software testing, build automation environments, and CI/CD pipelines, and programming experience with one or more languages: Embedded C, C++, Kotlin, Java, and Python.

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