Industry: Medical Devices
Role: RA Specialist
Location: Huddersfield (Hybrid)
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.
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
Private Healthcare Scheme
Company Pension Scheme
Company Bonus Scheme
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.