Job Title: Head of Quality Assurance/Regulatory Affairs

Company: Innovative MedTech Start-Up

Location: Cambridge

Start Date: ASAP

Salary Requirements: Above Market Rate Salary + Company Benefits

Who is this MedTech Start-up?

This company is an early-stage, venture backed MedTech start-up leading from the front in the Personal Diagnostics space. The team has over 30 years’ experience in Medical Device Diagnostics, immunology, virology and scaling VC backed companies on a global scale!

The R&D team are experts in microfluidics and blood analysis, and use this expertise to advance their offering on a daily basis. The client’s platform allows anyone with access to a smartphone to test themselves for a variety of diseases using just one fingerprick of blood. 

Sounds Interesting! What do they need the Head of QA/RA to do on a daily basis?

The role will involve managing and developing the businesses QMS (Quality Management System) to be compliant with ISO 13485. Maintain and build upon the current standard operations procedures in place (SOPs), ensuring that the records and references within the QMS are kept up to date.

A large part of the role will see you ensuring that the business meets regulatory requirements throughout the full product lifecycle and you will be accountable for internal as well as external audit processes.

There will be the chance for you to train staff in the operation of QA and control methods too! Keeping an eye on new regulations and relevant litigation to do with the industry will also be required as will managing regulatory agencies.

That’s something I’m interested in, what do I need to get the job?

-          5+ years’ experience of working in QA/RA roles within a medical device company.

-          Proficient with ISO 13485 QMS

-          Experience bringing IVDs to market (IE. Lateral Flow Tests)

-          Experience working in QA in a manufacturing environment

-          Experience having conducted audits both internal and external

Perfect, I’ve done this before! What can the company offer employees?

Competitive salaries as well as some unique company benefits, the start-up offer a progressive working environment with hybrid working in full swing. Everyone at the business is driven, motivated and organised in working towards a common goal… Using Technology to further the development of disease detection!

How do I apply?

Drop me an email to alex@socode.co.uk

OR

Drop me a message on LinkedIn: Alexander Flory