Regulatory Affairs Consultant

Overview

Industry: Medical Devices

Role: RA Specialist

Location: Huddersfield (Hybrid)

The Company

Our client, based just outside of Manchester is looking for a Regulatory Specialist to join their team.

So, what does a RA Consultancy Firm have to offer?

We cannot promise the work will be easy - but it will be WORTH it. The Capacity to develop professionally in RA alone is incredible with a client like ours. You will have access to some incredible resources in the form of your team and peers. Exposure to wider Regulatory Affairs matters is guaranteed - with a role that offers true RA scope.

The Role

Essentially we are on the hunt for an individual with the ability to not only contribute to the regulatory and quality project teams but with specialised interest in the reviewing of technical data and providing regulatory review and technical input.

Key Responsibilities include:

To contribute to regulatory and quality project teams

To compile and reviews Technical Files/Design Files etc for medical devices and in-vitro diagnostics

To review technical data as part of a project team

To provide regulatory review and technical input

To provide quality review and input

To become point of contact on medical devices and diagnostics information

To provide regulatory strategy for the filing of MD and IVD application in GB and EU

Regulatory documentation preparation (e.g. CE marking, 510K)

To continuously develop technical, interpersonal skills

To build and maintain expertise and develop a scientific profile in appropriate scientific disciplines, through publication and attendance at relevant scientific and regulatory meetings and/or conferences

Ad hoc activities / project work as required

What we need from you:

• Locally recognised professional Regulatory qualification, or working towards, e.g. TOPRA in UK
• Science graduate or equivalent
• 3+ years regulatory experience
• Experience of medical devices industry as well as hands on experience in the preparation of documents for submission
• Experience of the pharmaceutical industry would also be highly preferable

Benefits

Private Healthcare Scheme

Life Insurance

Company Pension Scheme

Company Bonus Scheme

Holidays

How to apply

If you're interested in hearing more, reach out TODAY!!

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.