Regulatory Affairs Manager - Digital Health
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It’s no surprise that today’s world demands online access to healthcare, and already telemedicine and e-health has demonstrated its extraordinary value to millions of patients globally.
Zest Scientific’s recent partnership with an innovative, AI Driven Digital Health start-up has brought us together to seek a Regulatory Affairs professional who will drive certification to various Medical Device standards as the platform moves from servicing thousands of people to millions in partnership with the NHS, and globally in the longer term.
In return, they’re offering a chance to be an early addition to their team in London and a fantastic opportunity to phase out external Regulatory support, becoming the Lead Regulatory Affairs professional as they scale.
What experience do they need?
- Strong experience in Medical Device Regulations (ISO 13485; 21 CFR 820; 510K etc.)
- Good understanding and experience in implementing ISO 27001, GDPR and other privacy and data protection standards.
- Background in liaising with and/or making submissions according to the Medical Device Directive (MDD) in the EU, FDA, and other regulatory agencies.
- Exposure to the process of registering Software as a Medical Device (SaMD) would be particularly desirable; however given the relative infancy of the DTx market, they will also consider people with wider Medical Device experience, providing strong software exposure remains.
- Comfortable working in a start-up environment amidst a comparatively small team.
- Proven ability to take initiative and work cross-functionally.
Who would you be working with?
- A start-up and emerging leader in the Digital Health space.
- With emergence of Covid-19, they’ve seen a huge surge in the demand for their platform which has given them a kick-start they’ve used to demonstrate their value to global health services.
- Having secured funding and partnered with the NHS, they’re now in the process of scaling up operations dramatically and this position’s aim will be to watertight their offering through certification to meet increased demand.
- A business who understands good work/life balance – they’re currently working from home and will be conducting interviews remotely in the first instance. The long term plan is to offer some form of home-working for this position.
What can they offer you?
This is a progression opportunity.
At present, the business is relying on consultancy services for their Regulatory management. Whilst this has worked well, the aim is to bring someone into the business who can take initiative in phasing this support out gradually and progress into a more senior Regulatory Affairs Lead position.
By this time, the business should have scaled significantly to allow for this individual to expand operations globally and manage the regulatory strategy for such an expansion accordingly.
In order to secure the services of the right candidate, the client has agreed to be as flexible in bringing their new Regulatory Affairs Manager on-board.
A consultant at Zest would be happy to give you more information following an application and a conversation as to your experience.
Zest Scientific – or any other division of Zest Business Group – will only ever submit your information to any client after meeting three requirements 1) You know who the company is; 2) You understand the specific role we’re working on; 3) We have your express consent to be represented. All applications are made in the strictest of confidence until those requirements are met.