regulatory affairs assistant in leeds

02 November 2018
ruby willard, randstad cpe
job type
£ 27,500 - £ 37,500 per year
apply now

leeds, yorkshire and the humber
sub specialism
job type
working hours
£ 27,500 - £ 37,500 per year
reference number
ruby willard, randstad cpe
apply now

job description

Are you an experienced Regulatory Affairs Assistant? Are you looking to take on a new challenge with a leading Medical Devices Manufacturer? If so we are looking for individuals just like you!

You will be providing full support to the regulatory project leader to ensure that all aspects of the registration programme are conducted in accordance with the requirements of the company and the regulators.

This opportunity is a contract role, initially for 12 months, working 37 hours per week Mon-Fri.


* Weekly pay
* Pension
* On site restaurant
* Free on site parking


* Provide support to the US for FDA submissions
* Facilitate the product registration activities in Europe by compiling appropriate dossiers, submissions and responses to regulatory bodies
* Maintain processes for submissions, interim notifications and periodic re-submissions
* Maintain information on regulatory requirements and the status of product registrations
* Liaise with product development groups, marketing and sales to co-ordinate timely approvals
* Provide support and advice to worldwide company colleagues, particularly product development, marketing and sales, concerning international regulatory requirements in Europe
* Establish relationships with country personnel, regulatory bodies and appropriate company personnel to expedite the product registration process

Qualifications / Experience required:

* Degree or equivalent preferred (Or relevant experience)
* Forward planning, organisational and time management skills
* Ability to use own initiative, speedily and efficiently handle enquiries and requests
* Work to tight deadlines and remain calm in stressful situations
* Good knowledge of MS Office products, such as Excel, Outlook and Word essential

If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.