regulatory affairs specialist in wokingham

posted
05 March 2019
contact
ruby willard, randstad cpe
job type
contract
salary
Competitive
apply now

posted
location
wokingham, south east
specialism
pharmaceutical
sub specialism
R&D
job type
contract
working hours
Full-Time
salary
Competitive
reference number
RASWOKJ
contact
ruby willard, randstad cpe
apply now

job description

Are you an experienced Regulatory Affairs Specialist? Are you looking to take on a new challenge with a leading FMCG business? If so we are looking for individuals just like you!

We are looking for a Regulatory Affairs Specialist to draw on relevant expertise and information from both internal and external sources and make a major contribution towards the preparation of any critical regulatory documentation for notifications in the Medical Device area.

This opportunity is an 8 month contract role, working 37 hours per week Mon-Fri.

Responsibilities:



* Ensuring that the company's products comply with relevant legislation and standards
* Keeping abreast of international legislation, guidelines and customer practices
* Keeping up to date with a company's product range
* Working knowledge of medical devices regulatory documentation
* Developing and writing clear strategies and arguments and explanations for new product licenses, modifications and license renewals
* Preparing submissions of license variations and renewals
* Setting and communicating timelines for license variations and renewal approvals
* Advising scientists and manufacturers on regulatory requirements
* Resolving complex issues as they arise
* Maintaining quality systems undertaking and managing regulatory inspections
* Reviewing company practices and providing advice on changes to systems
* Liaising with, and making presentations to regulatory authorities
* Submitting license applications to authorities to strict deadlines

Experience/Qualifications:



* Successful graduation in a Life Science degree or equivalent
* Proven expertise of medical device Regulatory Affairs on a European Basis
* Proven ability of interpreting legislation and impact to meet commercial needs
* Proven capability of successful working relationships with regulatory bodies
* Demonstrate an appreciation and understanding of the positive impact of regulatory in delivering business solutions
* Excellent communication and interpersonal skills, ability to influence and motivate
* Proven success at managing and driving a team to meet strategic goals and KPIs

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.