Senior Manager Regulatory Affairs

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Senior Manager Regulatory Affairs

At ONWARD we're looking for a Senior Manager Regulatory Affairs to join our team.
Full-time · Lausanne

About the job

The Senior Manager Regulatory Affairs at ONWARD Medical holds a pivotal role in leading the Regulatory Team. You are responsible for defining the regulatory pathway, providing expert regulatory guidance and support to technical teams throughout the product lifecycle, from design and development to evaluation, labelling, and marketing. Your primary focus is ensuring regulatory compliance with applicable standards.


  • Act as PRRC (Person Responsible for Regulatory Compliance) per MDR Article 15

  • Provide crucial regulatory support to the development team for the creation of a comprehensive Design History File and Technical Documentation.

  • Collaborate closely with cross-functional teams, offering regulatory guidance in all aspects of product design, development, evaluation, labelling, and marketing.

  • Oversee packaging and labelling requirements.

  • Create Submission Files in accordance with 21 CFR 820 and with the General Safety and Performance Requirements (GSPR) checklist.

  • Drive and coordinate FDA submissions, working closely with both internal teams and external consultants.

  • Continuously assess the current regulatory activities against newly published guidance related to the Medical Device Regulation (MDR) and standards.

  • Conduct traceability and compliance assessments to demonstrate adherence to applicable standards (e.g., 14708-1, 14708-3, IEC 60601-1), and collaborate with test houses as needed.

  • Collaborate with the engineering team to execute Failure Modes and Effects Analysis (FMEA) in alignment with ISO 14971 requirements as part of technical file updates.

  • Actively participate in ISO audits and provide valuable support to the Quality department in preparing for these assessments.

  • Lead, mentor, and manage a team of Regulatory Specialists.

About you

  • You have a Bachelor or Master’s degree in Engineering, or a similar degree in Quality or Regulatory

  • You have at least 7+ years of relevant Medical device experience, preferably experience with class III devices such as active implantable medical device.

  • Strong understanding of translating standards into compliance/traceability reports. Good knowledge and understanding of the quality management system (ISO 13485), and other horizontal and technical standards such as ISO 14708-1/-3, ISO 14971, IEC 62304, IEC 60601, ISO 62366, ISO 15223-1

  • Experience in facing the ISO audit

  • A high energy, self-motivated, pro-active personality able to work in a diverse team within a startup company; willing to help colleagues.

  • Fluent in English, mastering of French language is highly appreciated.


Supervision of direct reports, reporting to the Senior Director Regulatory Affairs (based in the US).

Apply for the job

Do you want to join our team as our new Senior Manager Regulatory Affairs? Then we'd love to hear about you!