Head of Quality and Regulatory Affairs

Biscuit Factory - London Quality

03 Jan 2024

Biscuit Factory - London

Quality

Quality Assurance

Full Time

1

22 Jan 2024

About us:

Machine Medicine Technologies is facilitating the next generation of neurotherapeutics by building software for the intelligent, personalised optimisation of neuromodulation and other precision therapeutics. Our flagship product, Kelvin, is in use at multiple deep brain stimulation (DBS) sites across the globe, enabling the collection of large datasets of unparalleled quality. This data is being utilised to develop a SaMD (Software as Medical Device) tool for automated clinical assessment of Parkinson’s disease. 

The FDA awarded our technology Breakthrough Device Designation, recognizing its potential to revolutionize the MedTech industry.

Based in central London (Bermondsey), our company is growing rapidly with 30+ full-time employees and over £6.5M in funding. We have published papers in numerous high-quality, peer-reviewed journals, including Sensors, Intelligence-Based Medicine, and Nature Parkinson’s Disease.

Benefits

  • 25 days annual leave (+ Bank Holidays)
  • Unlimited coffee & tea at the office
  • Private Medical coverage with Vitality Health
  • Cycle to work scheme
  • Electric car scheme

About the role:

The Quality team at our company plays a pivotal role in ensuring the excellence of our products and services. The team guarantees that our medical device functions with pinpoint accuracy, high reliability, and utmost safety. Their efforts go beyond our internal operations; they provide the assurance needed to not only meet but consistently exceed the expectations of regulatory bodies, healthcare professionals, patients, and clients.

It is an exciting time to join the company as we embark on two ambitious missions: 

  • Submitting Kelvin-Parkinson’sDisease technical documentation to FDA for market clearance
  • And support the design and development of new SaMD for other movement disorders, under the Kelvin series

Reporting directly to the CEO, the Head of Quality and Regulatory Affairs will play a vital role as a member of the leadership team, and leading a team of three. 
If you are a self-starter with an entrepreneurial spirit, passion for the field and perseverance towards a goal, you will fit right in. We are hiring A players that perform the absolute best. This is a superb opportunity for an ambitious Quality professional, with relevant previous experience, to take personal ownership and deliver outstanding results.

Key Responsibilities

Quality and Regulatory

  • Maintain the highest degree of product quality and quality systems, grounded by the ability and vision to anticipate and prevent quality and/or regulatory problems.
  • Ensure compliance with ISO 13485 Quality Management System and maintain ISO 27001 certification.
  • Ensure all external audits with Notified Bodies, Regulatory Authorities, and Customers are managed to ensure a positive outcome.
  • Ensure compliance with local and international regulatory compliance in line with relevant legislation
  • Oversee the maintenance of  product technical documentation (DHF/DMR/DHR)
  • Perform product registrations in relevant jurisdictions, particularly the US and EU.
  • Report vigilance issues and information security incidents to regulatory authorities in terms 

Leadership and Planning: 

  • Grow, motivate and empower the Quality team, through performance reviews and development.
  • Define quality strategy and implement procedures. Set objectives, measure achievement of goals and support the business in achieving its overall strategic goals.

Need-to-haves

  • Strong inclination towards and appetite for technology and creative thinking. One of the key aims is to minimise the viscosity a QMS imposes, eliminate unnecessary steps, and automate processes wherever possible. 
  • Degree or higher in Sciences (Life or Physical) 
  • Knowledge and experience in medical device quality systems and regulatory processes including ISO 13485, ISO 14971, ISO 27001, 21 CFR Part 11, 21 CFR Part 820, MDR 2017/745, IEC 62304.
  • Experience with Software as a Medical Device (SaMD)
  • Proven track record in interactions with Notified Bodies/Regulatory Authorities, especially the FDA
  • Certified in Internal/Supplier Auditing
  • Proven experience in a relevant position.

Nice-to-haves 

  • Experience with GDPR and HIPAA
  • Quality certification: ISO 9001

Are you interested in the role but do not tick all the boxes? We encourage you to submit your CV. We consider all applications.