Senior Consultant - Software Quality Assurance
Hardian Health is a digital health technology consultancy which focuses on accelerating innovative software, including artificial intelligence, to the clinical frontline by providing clinical, regulatory, health economics and IP specialist services to a global range of industrial partners, researchers, investors and healthcare providers.
We are looking to fill a senior role in our Quality Assurance & Regulatory Affairs (QARA) team. The ideal candidate will have a demonstrable track-record of technical competence in the quality assurance of compliant software (both as and in a medical device), including artificial intelligence. We are seeking someone with a desire to help lead the existing QARA team, while building a fast-growing niche consultancy in the health technology sector. The role requires a passion for quality assurance, cutting-edge medical device software and attention to detail.
We are looking for someone technically competent, astute, experienced, and proactive who wants to continue their career in QARA for medical device software. The ideal candidate will have consulting experience, and will have evidence of multiple CE marked and FDA authorised SaMD/AIaMD devices they have worked on. You will be leading regulatory submissions for cutting-edge AI and Software as a Medical Device products in all global jurisdictions, supported by our exceptional multi-disciplinary regulatory and clinical teams. The role will be end-to-end, managing resources and budgets, as well as delivering to the level of regulatory excellence that Hardian is known for.
Overview of company and job details
Fully remote working (UK location of your choice), we are a virtual company with quarterly in person meet ups.
FTE Salary: up-to ÂŁ90,000 PA + structured bonus scheme
Company benefits include private health insurance (via salary sacrifice) and pension scheme
Company laptop and remote office set-up
Flexible work hours (40 per week), work when you want, fit work around your life.
28 day annual holiday allowance, guaranteed Christmas break
Details of the role
Reports to the Director of QARA.
Takes on overall responsibility for multiple quality assurance projects, including:
Deployment and validation of Quality Management Systems, supported by our junior QARA team
Creation of MDF/ DHF documentation for clients, supported by our in-house QARA and clinical teams.
Interacting with international regulators on behalf of clients.
Leading client meetings, contributing to business development, problem solving for clients, and delivering on-time.
Mentoring and training of junior QARA staff.
Involved in internal resource allocation for projects.
Opportunities to gain further qualifications and experience, including presenting and speaking externally on behalf of Hardian.
Skills and experience
Essential:
Significant experience of SaMD/AIaMD medical device file and QMS preparation, both CE and FDA, with multiple products, ideally in a consulting capacity.
Experience of implementing process for and working to the following standards: IEC 62304, IEC 82304-1, IEC 62366-1, ISO 13485:2016, ISO 14971:2019
An ability to pick up new tools and systems quickly is essential - our systems, and our clients’ systems are all digital.
Purpose driven. Everything we do is to help improve access to cutting edge technology for patients.
Ability to communicate complex subject matter to multiple stakeholders.
Ability to diligently manage multiple projects simultaneously and prioritise workload.
Must already have the right to work in the UK. Hardian does not offer sponsorships.
Highly Desirable:
Prior consulting experience
Links to regulatory authorities and standards committees.
Experience in project management (interpersonal leadership, rather than administration).
Interview process:
There will be up to three rounds of interviews.
The first round will be with our Operations Manager, who will meet with you to discuss your experience and to answer any questions you may have about the company and the role.
The Second round will be with the Operations Manager and the Director of QARA and will have a technical focus.
The final round will be a short call with our MD and Director of Technology.
All interviews will be conducted remotely via Google Meet.
