Regulatory Affairs Specialist

A high tech Medical Device start-up are currently looking for an Regulatory Affairs Specialist to join their team. They’ve just received FDA approval on their first product, of which they are now looking to move into production, and moving forward will be developing their next generation of products over the next few years. Their tech is novel and patented and will have a huge positive impact on people’s lives.

In this role, you will be working closely with the Head of QARA to support regulatory approvals and quality engineering audits and processes, ensuring regulatory submissions are compliant with medical device regulations and standards.

This is a highly interesting role, where you will have varied responsibilities, with the potential to progress and build a team around you as the business grows. They are ideally looking for someone to be onsite 2-3 days per week but could potentially look at predominantly remote roles (2-3 days onsite per month) for the right person.

Responsibilities:

Prepare and update technical documents for UK and EU product submissions

Evaluate and approve product and process changes to ensure regulatory adherence

Assist in creating and maintaining clinical evaluation documents per EU and UK MDR

Maintain and update Post-Market Surveillance and Clinical Follow-up activities

Assess and approve product labelling for regulatory compliance

Help prepare and submit 510(k) applications for the US market

Support quality in managing complaints, change control, deviations, and CAPAs

Aid in global product registration efforts

Provide regulatory guidance to internal teams as needed

Comply with relevant regulations, standards, and accreditations, such as ISO 13485, ISO 14001, UK and EU MDR, and CFR 820

Experience:

2+ years’ experience in a similar role (Regulatory Affairs within medical device industry)

Ideally educated to degree level

Experience of MDD, MDR and ideally FDA regulations

Ideally experience with class IIa and above medical devices

Knowledge of ISO 13485

Strong attention to detail