We are looking for a Quality & Regulatory Affairs Manager. You will build and manage our
regulatory and quality systems for Software as a Medical Device (SaMD) development and clinical
studies in collaboration with experienced regulatory and quality advisors. You will translate
regulatory strategy into practical processes and documentation while driving the day-to-day
execution of our quality management system. You will work closely with experienced regulatory
and quality advisors as well as company leadership to implement and operationalise our regulatory
strategy and quality systems.
This is a hands-on operational role at an early-stage neurotech startup, requiring strong
operational execution, ownership, and the ability to build and manage processes from scratch in
a collaborative environment. It offers the opportunity to work closely with experienced regulatory
and quality professionals while gradually taking increasing ownership as the company grows.
Responsibilities
Foster a quality culture based on responsibility, transparency, and benevolence, suited to a small, highly engaged team.
Work closely with management and third-party stakeholders to ensure alignment between strategy and execution.
Establish, implement, and maintain a lean, risk-based Quality Management System in accordance with ISO 13485, EU MDR, Swiss MeDO and FDA QMSR.
Act as Management Representative and support PRRC activities under EU MDR requirements, in collaboration with internal and external regulatory experts.
Own and implement risk management activities in accordance with ISO 14971, including hazard identification, risk analysis, risk control, and benefit-risk justification.
Support the team in embedding quality-by-design principles within agile and/or hybrid
Prepare the organisation for certification audits (ISO 13485), notified body interactions, and potential Competent Authorities inspections.
Translate regulatory strategy into practical processes such as preparing technical documentation and drafting SOPs.
Provide regulatory and quality oversight for medical device development activities across defined regulatory pathways.
Ensure the compliance of medical device technical documentation with the applicable regulatory requirements and proactively address compliance issues to uphold regulatory standards.
Support and manage direct interactions with relevant National Competent Authorities in the EU, CH and the US and, where applicable, notified bodies.
Requirements
MSc in Biomedical Engineering or a related Life Science discipline, with at least 3 years of experience in regulatory/quality affairs within the medical device industry (PhD is a plus).
Experience with SaMD is a requirement.
Good understanding of the EU, Swiss and US medical device regulations, guidance and standards, including the MDR (EU) 2017/745, the FDA 21 CFR Part 820 and ISO 13485 requirements.
Experience interacting with National Competent Authorities (e.g. Swissmedic, FDA) and
Hands-on experience with implementing or working within a QMS.
Familiarity with relevant standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366-1 and IEC 81001 5 1)
Strong organisational and communication skills, with the ability to work across disciplines.
Fluency in English and a valid work permit for Switzerland is required (we are not able to offer permit sponsorship at this time). French is a plus.
What we offer
Full-time position, starting as soon as possible.
Flexible working hours and hybrid set-up, with on-site workdays in Geneva.
Competitive salary CHF 100’000 – 130’000, 5 weeks of vacation, opportunity for long-term career advancement and equity participation.
A collaborative, interdisciplinary team with backgrounds in neuroscience, tech, and business.
The chance to shape an early-stage clinical product with direct patient impact.
An open, supportive culture that values initiative, curiosity, and passion.
#J-18808-Ljbffr
regulatory and quality systems for Software as a Medical Device (SaMD) development and clinical
studies in collaboration with experienced regulatory and quality advisors. You will translate
regulatory strategy into practical processes and documentation while driving the day-to-day
execution of our quality management system. You will work closely with experienced regulatory
and quality advisors as well as company leadership to implement and operationalise our regulatory
strategy and quality systems.
This is a hands-on operational role at an early-stage neurotech startup, requiring strong
operational execution, ownership, and the ability to build and manage processes from scratch in
a collaborative environment. It offers the opportunity to work closely with experienced regulatory
and quality professionals while gradually taking increasing ownership as the company grows.
Responsibilities
Foster a quality culture based on responsibility, transparency, and benevolence, suited to a small, highly engaged team.
Work closely with management and third-party stakeholders to ensure alignment between strategy and execution.
Establish, implement, and maintain a lean, risk-based Quality Management System in accordance with ISO 13485, EU MDR, Swiss MeDO and FDA QMSR.
Act as Management Representative and support PRRC activities under EU MDR requirements, in collaboration with internal and external regulatory experts.
Own and implement risk management activities in accordance with ISO 14971, including hazard identification, risk analysis, risk control, and benefit-risk justification.
Support the team in embedding quality-by-design principles within agile and/or hybrid
Prepare the organisation for certification audits (ISO 13485), notified body interactions, and potential Competent Authorities inspections.
Translate regulatory strategy into practical processes such as preparing technical documentation and drafting SOPs.
Provide regulatory and quality oversight for medical device development activities across defined regulatory pathways.
Ensure the compliance of medical device technical documentation with the applicable regulatory requirements and proactively address compliance issues to uphold regulatory standards.
Support and manage direct interactions with relevant National Competent Authorities in the EU, CH and the US and, where applicable, notified bodies.
Requirements
MSc in Biomedical Engineering or a related Life Science discipline, with at least 3 years of experience in regulatory/quality affairs within the medical device industry (PhD is a plus).
Experience with SaMD is a requirement.
Good understanding of the EU, Swiss and US medical device regulations, guidance and standards, including the MDR (EU) 2017/745, the FDA 21 CFR Part 820 and ISO 13485 requirements.
Experience interacting with National Competent Authorities (e.g. Swissmedic, FDA) and
Hands-on experience with implementing or working within a QMS.
Familiarity with relevant standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366-1 and IEC 81001 5 1)
Strong organisational and communication skills, with the ability to work across disciplines.
Fluency in English and a valid work permit for Switzerland is required (we are not able to offer permit sponsorship at this time). French is a plus.
What we offer
Full-time position, starting as soon as possible.
Flexible working hours and hybrid set-up, with on-site workdays in Geneva.
Competitive salary CHF 100’000 – 130’000, 5 weeks of vacation, opportunity for long-term career advancement and equity participation.
A collaborative, interdisciplinary team with backgrounds in neuroscience, tech, and business.
The chance to shape an early-stage clinical product with direct patient impact.
An open, supportive culture that values initiative, curiosity, and passion.
#J-18808-Ljbffr
