Head of Regulatory and Quality

Vor 6 Tagen

Munich, Bayern, Deutschland Amplifold Vollzeit 60.000 € - 120.000 € pro Jahr

About us

Amplifold is pioneering the next generation of molecular diagnostics through breakthrough molecular design and DNA nanotechnology. By reimagining how biomolecules are assembled and interact, we are unlocking new levels of precision, speed, and sensitivity in immunoassays and related diagnostic platforms.

We are a small, ambitious team of scientists and entrepreneurs with a shared drive to push the boundaries of diagnostic performance. At Amplifold, everyone contributes to shaping our technology, our culture, and our impact - combining scientific rigor with an entrepreneurial spirit.

Our goal is to achieve successful regulatory approval of our products in Europe and the United States, ensuring that our innovations can reach patients and clinicians worldwide. To support this mission, we are seeking an experienced Head of Regulatory and Quality to lead the establishment and advancement of our quality and regulatory systems.

We believe the future of diagnostics lies in the intelligent design of molecular systems, enabling faster, more reliable, and more informative tools for human health.

Your Responsibilities

  • Establish, implement, and continuously improve a QMS according to ISO including MDR requirements and FDA QSR).
  • Take strategic responsibility for all regulatory activities (CE-IVD under IVDR, FDA clearance/approval such as 510(k), De Novo, or PMA).
  • Prepare and maintain the required Technical Documentation and support audits and inspections.
  • Collaborate closely with R&D and Operations to integrate regulatory and quality requirements early in product development.
  • Develop and implement lean, efficient processes suitable for a start-up environment.
  • Responsible for training, education, and raising awareness on quality and regulatory topics across the team.
  • Act as primary contact for external stakeholders such as authorities, Notified Bodies, and partners.
  • Build and lead a small but growing Regulatory & Quality team.

Your Profile

  • Degree in life sciences, engineering, medical device technology, or equivalent qualification.
  • At least 5 years of professional experience in Regulatory Affairs and Quality Management for in vitro diagnostics or medical devices.
  • Proven track record in building and managing a QMS according to ISO ideally also ISO 14971, IEC
  • Strong knowledge of European IVDR and FDA regulations (21 CFR Part 820, QSR).
  • Experience with regulatory strategies and submissions in both Europe and the USA.
  • Successful track record in conducting or supporting audits/inspections (Notified Body, FDA, ISO).
  • Hands-on experience in start-ups or small companies with a focus on lean processes and pragmatic solutions.
  • Ability to translate complex regulatory requirements into actionable processes.
  • Strong leadership and communication skills, high level of initiative, and a hands-on mentality.
  • Fluent English skills (written and spoken); German is a plus.

We Offer

  • The opportunity to shape an IVD start-up and take the lead in regulatory pathways for Europe and the USA.
  • A dynamic, multidisciplinary team with flat hierarchies and short decision-making processes.
  • Room to design innovative, lean processes and contribute to sustainable company growth.
  • Attractive compensation package including participation options.
  • This position is based at the Biotech Campus Martinsried, Munich, Germany.
  • The position requires a mix of remote work and on-site work at our office.

Please submit your application to before October 23rd 2025.

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