Head of Quality and Regulatory Affairs

3 weeks ago

London, United Kingdom Machine Medicine Technologies Full time

Aboutus:

Machine Medicine Technologiesis facilitating the next generation of neurotherapeutics bybuilding software for the intelligent personalised optimisation ofneuromodulation and other precision therapeutics. Our flagshipproduct Kelvin is in use at multiple deep brain stimulation (DBS)sites across the globe enabling the collection of large datasets ofunparalleled quality. This data is being utilised to develop a SaMD(Software as Medical Device) tool for automated clinical assessmentof Parkinsons disease.

The FDA awarded ourtechnology Breakthrough Device Designation recognizing itspotential to revolutionize the MedTechindustry.

Based in central London (Bermondsey)our company is growing rapidly with 30 fulltime employees and over6.5M in funding. We have published papers in numerous highqualitypeerreviewed journals including Sensors IntelligenceBased Medicineand Nature ParkinsonsDisease.

Benefits

  • 25days annual leave ( Bank Holidays)
  • Unlimitedcoffee & tea at the office
  • Private Medicalcoverage with Vitality Health
  • Cycle to workscheme
  • Electric carscheme

About therole:

The Quality team at ourcompany plays a pivotal role in ensuring the excellence of ourproducts and services. The team guarantees that our medical devicefunctions with pinpoint accuracy high reliability and utmostsafety. Their efforts go beyond our internal operations; theyprovide the assurance needed to not only meet but consistentlyexceed the expectations of regulatory bodies healthcareprofessionals patients and clients.

It is anexciting time to join the company as we embark on two ambitiousmissions:

  • SubmittingKelvinParkinsonsDisease technical documentation to FDA for marketclearance
  • And support the design anddevelopment of new SaMD for other movement disorders under theKelvin series

Reporting directly tothe CEO the Head of Quality and Regulatory Affairs will play avital role as a member of the leadership team and leading a team ofthree.
If you are a selfstarter with an entrepreneurialspirit passion for the field and perseverance towards a goal youwill fit right in. We are hiring A players that perform theabsolute best. This is a superb opportunity for an ambitiousQuality professional with relevant previous experience to takepersonal ownership and deliver outstandingresults.

KeyResponsibilities

Qualityand Regulatory

  • Maintain the highestdegree of product quality and quality systems grounded by theability and vision to anticipate and prevent quality and/orregulatory problems.
  • Ensure compliance with ISO13485 Quality Management System and maintain ISO 27001certification.
  • Ensure all external audits withNotified Bodies Regulatory Authorities and Customers are managed toensure a positive outcome.
  • Ensure compliancewith local and international regulatory compliance in line withrelevant legislation
  • Oversee the maintenance ofproduct technical documentation(DHF/DMR/DHR)
  • Perform product registrations inrelevant jurisdictions particularly the US andEU.
  • Report vigilance issues and informationsecurity incidents to regulatory authorities in terms

Leadership and Planning:

  • Grow motivate and empower the Qualityteam through performance reviews anddevelopment.
  • Define quality strategy andimplement procedures. Set objectives measure achievement of goalsand support the business in achieving its overall strategicgoals.

Needtohaves

  • Stronginclination towards and appetite for technology and creativethinking. One of the key aims is to minimise the viscosity a QMSimposes eliminate unnecessary steps and automate processes whereverpossible.
  • Degree or higher in Sciences (Lifeor Physical)
  • Knowledge and experience inmedical device quality systems and regulatory processes includingISO 13485 ISO 14971 ISOCFR Part 11 21 CFR Part 820 MDR 2017/745 IEC62304.
  • Experience with Software as a MedicalDevice (SaMD)
  • Proven track record ininteractions with Notified Bodies/Regulatory Authorities especiallythe FDA
  • Certified in Internal/SupplierAuditing
  • Proven experience in a relevantposition.

Nicetohaves

  • Experience with GDPRand HIPAA
  • Quality certification: ISO9001

Are you interested in the rolebut do not tick all the boxes We encourage you to submit your CV.We consider allapplications.


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