Flow Neuroscience has developed a new, highly scalable depression treatment that has the potential to completely change the way the world treats mental health.

Our headset is already being used by the NHS, over 400 private clinics and 40K users.

The data from these users, our own clinical trial, and extensive research in the scientific literature indicates that 57% of people that use Flow will be depression-free, and over two thirds will have an improvement in their symptoms.

We’re backed by leading VCs (Khosla Ventures) and have raised over $20m to date.

The role:

We are seeking an experienced and highly knowledgeable Quality Manager and Regulatory Affairs Specialist to join our team.

The ideal candidate will have a strong background in medical device quality assurance, EU Medical Device Regulations (MDR) and FDA medical device regulations. 

The candidate should possess excellent technical and analytical skills, with a focus on managing technical files, ensuring compliance with regulatory requirements, and supporting the design and development of medical devices. Bonus qualifications include expertise in UK DTAC, usability engineering and biocompatibility.

Responsibilities:

- Manage and oversee regulatory activities related to medical device projects, ensuring compliance with EU MDR, UKCA, and FDA regulations, and other applicable international regulations and guidelines.

- Develop and maintain our QMS and technical files.

- Prepare and submit regulatory documents to the FDA and relevant European competent authorities, including EU MDR submissions, substantial changes,  FDA pre-market notifications, 510k, PMA applications and amendments.

- Coordinate and liaise with cross-functional teams to gather necessary technical information for regulatory submissions and ensure compliance with software regulations, such as IEC 62304 and FDA Software Validation Guidance.

- Lead the quality assurance work to ensure maintained and improved quality of our products and processes.

- Conduct risk analysis and assessment for medical devices, identifying potential hazards and proposing mitigation strategies according to ISO 14971.

- Provide regulatory guidance and support to R&D teams during the design and development phases of medical devices, including adherence to design control processes.

- Stay up to date with the latest EU and US FDA regulations, guidance documents, and industry best practices related to medical devices and software.

- Collaborate with internal teams to perform usability engineering studies and ensure that medical devices are designed with a focus on user needs, safety, and compliance with applicable usability engineering standards.

- Assist in the evaluation of biocompatibility testing and documentation to ensure compliance with relevant standards and regulations, such as ISO 10993.

Requirements:

- Bachelor's degree in a relevant scientific or engineering field. Advanced degree preferred.

- Minimum of 10 years of experience in quality assurance and regulatory affairs for medical devices, with a proven track record of successful EU MDR submissions and bringing devices to the EU and preferably also the US market.

- Deep knowledge of EU MDR regulations.

- Proficient in managing technical files and documentation, including risk analysis, design control, and active devices.

- Familiarity with medical device software regulations and standards, such as IEC 62304 and FDA Medical device Software requirements.

- Strong analytical and problem-solving skills, with the ability to assess complex regulatory requirements and develop appropriate strategies.

- Excellent written and verbal communication skills, with the ability to effectively communicate regulatory requirements and recommendations to cross-functional teams.

- Detail-oriented with a high level of accuracy in regulatory documentation and submissions.

- Ability to work independently and collaboratively in a fast-paced environment, managing multiple projects and priorities simultaneously.

Bonus Qualifications:

- Experience of working with neuromodulation devices.
- Experience of managing FDA Class III products and PMA submissions.
- Experience of data and privacy regulation such as GDPR, UK DTAC, HIPAA.
- Experience from other markets such as Australia, Canada and the Middle East.
- Experience in usability engineering and conducting human factors studies for medical devices.
- Knowledge of biocompatibility requirements and standards, such as ISO 10993.

Desired personal qualities:

- Creativity
- Integrity
- Intellectual breadth
- Ability to admit when wrong
- Ability to work in a diverse team
- Sense of humour
- Emotional openness

What we can offer

- Ownership - be responsible for QA/RA at Flow.
- Flexible working hours - we measure performance based on delivery, not on face time.
- Remote/hybrid working - it would be great if you could come to one of our offices (London or Malmö, Sweden) 1 day a month.
- Be part of a high growth start up at its early stage.
- Share options.

Website:

https://flowneuroscience.com