Head of Quality and Regulatory Affairs (ISO13485)

· Cambridge, Cambridgeshire
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor
Compensation £60-90K negotiable

Salary - £60-90K negotiable

Location - Cambridge/remote

Do you have experience helping companies secure regulatory approval for standards like ISO27001 or ISO13485?

Have you designed and implemented these processes successfully?

Interested in doing it again for a product with a huge benefit to society?

We might have just the job for you.....

Zetta Genomics was spun out of Cambridge University in 2018 with a clear vision to become the gold standard for genomic information in precision medicine.

Our genomics platform employs big data technology and best practice security to leverage genomic data benefits while preserving data privacy to enable a faster diagnosis to patients.

We are a team of highly motivated and ambitious people who really care about the positive impact our product can have on wider society, in helping clinicians make faster, better decisions for optimum patient outcomes.

We are now looking for a Head of Quality and Regulatory Affairs to build the department and the processes to make it effective.

The Role

As the Head of Quality and Regulatory at Zetta you will head up a department of four that includes a Software Quality Manager, IVD Regulatory Specialist and Documentation Manager. You will run this department and be responsible for all future hires across quality and regulatory.

This position is crucial to the continued growth of Zetta and comes with two key areas of responsibility.

On the quality side of the equation you will inherit a range of company policies and procedures we have documented but not yet implemented fully. It's crucial we are able to offer an audit trail on the work we complete so you will need to work with the wider business to ensure that they are followed effectively. While we are confident about the processes we have designed you’ll have a remit to improve them further where possible.

You’ll also need to design and implement change management processes to ensure that as we develop our product we are able to secure and maintain the regulatory approvals we need.

On the regulatory side we are working towards ISO13485 and ISO27001 which you will lead. One of our immediate priorities is to secure a CA mark in the UK within the next 6 months. Through having effective quality and change processes you will generate the information to secure the regulatory approvals we need.

Our plans don’t stop with the UK though, once completed we will then be seeking similar approvals in the EU, US and globally.

The Experience

You must have significant experience of managing quality and regulatory processes within life sciences, ideally Bioinformatics.

You must have been responsible for helping a previous employer to secure certification for business management standards such as ISO27001 and ISO13485. We’ll want to hear about that process, step by step, the challenges you faced and why it was successful.

Previous experience of designing meticulous and effective quality and change processes is crucial. We will want to hear about the processes you designed and how you drove adoption, the challenges you faced and how you overcame them.

Training and support for the wider business is important so we’ll want to hear about how you have approached this in the past. How did you convince resistant staff to follow processes?

You must have managed people before, even if you have not been leading the whole department.

You should be an expert in the latest developments in quality and information security management best practice. We’ll want to hear about how you keep up to date with these things.

Managing projects effectively is important so you should be familiar with a variety of approaches (agile, waterfall) and tools like Jira and Confluence.

Finally in this role you will need to coordinate distributed teams to deliver this work against some challenging deadlines. We’ll want to know how you have approached similar work in the past to ensure it was delivered on time.

Why Zetta?

This role presents a unique opportunity to drive quality and regulatory excellence for a cutting edge product.

We are all driven by a strong sense of purpose. We take great satisfaction in knowing that the work we do can help patients access the treatment they need more quickly and ultimately that can change outcomes.

We are a startup business with no legacy technology to manage. We offer a clean slate, built on tried and tested technology.

You’ll have full remit to grow your department as you see fit and you will have the resources available to do so.

You’ll immediately have a strong voice within the business and work with our senior management team to grow the business.

This is a fast growing company that is open to change and values the adoption of best practice as early as possible.

Get in touch for full details.

Zetta will never discriminate on the basis of gender, race, colour, religion or belief, sexual orientation, disability, age, marital status, or any other protected class

Thank You

Your application was submitted successfully.

  • Location
    Cambridge, Cambridgeshire
  • Employment Type
  • Minimum Experience
    Senior Manager/Supervisor
  • Compensation
    £60-90K negotiable