Regulatory Affairs Manager

Cambridge Heartwear Ltd, is looking for a Regulatory Affairs Manager who has experience in working with Class 2a devices within a medical environment.

The Regulatory Affairs Manager will act as the critical liaison between our company, the

product we sell and the regulatory authorities. As well as be expected to have knowledge

and experience with pre- and post-market medical device regulations.

The Regulatory Affairs Manager will have ECG device experience and FDA lead experience,

regulatory and quality management experience within a medical device environment.

The Regulatory Affairs Manager will have a FDA 510K experience; experience with working

with medical devices and also regulatory experience of 60601-1.

Job description

Core job responsibilities

• Preparation of regulatory submission for product approvals (e.g. 510k

documentation to FDA).

• Provide regulatory expertise to scientists and senior management and assist with the

preparation and submission of regulatory documentation.

• Support the maintenance of regulatory files and tracking databases to ensure prompt

and accurate access to company regulatory information (concerning current, pending

and future approvals and renewals)

• Ensure that our heartsense device comply with the regulations of the regions where

they want to distribute them.

• Keep up to date with national and international legislation, guidelines and customer

practices.

• Collect, collate and evaluate scientific data from a range of sources.• develop and write clear arguments and explanations for new product licences and

licence renewals.

• Prepare submissions of licence variations and renewals to strict deadlines.

• Monitor and set timelines for licence variations and renewal approvals.

• Work with specialist computer software and resources.

• Write clear, accessible product labels and patient information leaflets.

• Plan and develop product trials and interpret trial data.,

• advise scientists and manufacturers on regulatory requirements.

• Provide strategic advice to senior management throughout the development of a

new product.

• Project manage teams of colleagues involved with the development of updated

versions.

• Undertake and manage regulatory inspections.

• Review the company practices and provide advice on changes to systems.

• Liaise with, and make presentations to, regulatory authorities.,

• Negotiate with regulatory authorities for marketing authorisation.

• Take part in the development of marketing concepts and approve packaging and

advertising before a product's release.

Requirements:

• Minimum of 5 years experience in a Regulatory position

Cambridge Heartwear’s ethos and mission is to improve the equality of opportunity for all

and not just for the chosen few. We are a cutting-edge med tech and AI company. We have

developed a next generation heart and cardiovascular function monitor which uses AI to

diagnose heart rhythm and respiratory problems in real time.

The device is called Heartsense. It includes a multiple lead ECG, oxygen sensing,

temperature and tracking device which can be comfortably worn by patients for early

screening. It is also a female wearable friendly device.

We hope to use the heartsense device to improve detection of irregular and dangerous

heart rhythms and reduce the impact of stroke and stroke-related mortality and morbidity,

which affects 120,000 people in the UK each year.

We are looking for an experienced regulatory affairs specialist in medical devices (not

pharmaceuticals) and greater than 5 years' experience to kickstart their career in our

company in helping us realising our vision.

We are looking for a talented and enthusiastic regulatory affairs manager to join our

expanding company.

We are an equal opportunities and inclusivity employer and welcome applications from

people from all walks of life including those from disadvantageous and underprivileged

backgrounds.

If you are looking for a fantastic opportunity to develop your regulatory affairs learning,

Cambridge Heartwear is the place for you. For more information about this post please

email jennifer@camheartwear.com and sophie@camheartwear.com .

Applicants must have permission to work in the UK.

Starting salary is open to negotiation.