Cytocell Ltd. — Regulatory Affairs Associate
Cytocell, a leading manufacturer of IVD medical devices for the diagnosis of human genetic diseases and cancer is looking to recruit a Regulatory Affairs Associate, based in Cambridge, to assist in all aspects of regulatory requirements including, risk assessments, co-ordination of performance evaluations, maintaining technical files and preparation of documentation for registration and submission of products for worldwide markets.
To assist the Director of Regulatory compliance to ensure compliance of Cytocell’s products to applicable regulation and standards for the markets into which they are sold.
To assist with registrations and regulatory submissions to regulatory bodies as required.
To assist with the legalisation of documents and other document requested by distributors or regulatory authorities.
To assist with regulatory requirements throughout the design and development and performance evaluation processes ensuring technical files are maintained for all Cytocell’s products.
Tasks and Accountabilities:
- Completion of technical file documentation
- Assist with co-ordinating performance evaluation studies including investigational plans, study protocols and reports
- Assist where required with distributor registrations and with any necessary paperwork to facilitate importing Cytocell’s products.
- To assist with legalisation of documents
- Complete paperwork and other requirements for regulatory submissions
- Be involved in carrying out detailed risk assessments of IVD products
- Assist in timely reporting of any adverse events to the appropriate authorities distributors and customers
Qualifications and previous experience:
The candidate should have a background in a science related subject as well as some experience of working within a regulated environment such as ISO 13485 and the IVD directive. Experience of technical file documentation within the IVD / Medical Device industry is desirable but is not essential.
The candidate should
- Be a confident communicator with excellent IT skills
- Have strong attention to detail.
- Be flexible, well-organised and reliable
Cytocell offers a competitive salary commensurate with qualifications and experience, a performance related bonus scheme and a pensions and healthcare package.
If this role is of interest and you believe you have the relevant experience then please send a copy of your CV to Mrs Darleen Welford:- Cytocell Ltd, 3-4 Technopark Newmarket Road, Cambridge CB5 8PB or firstname.lastname@example.org
Date Posted: 25 March 2015
UK Sales and Application Specialist - Next Generation Sequencing
In order to strengthen our commercial team we are seeking to recruit a talented Sales and Application Specialist for the UK. In this commercial role you will be responsible for growing Multiplicoms’ business in the UK market.
This position offers a competitive remuneration package and benefits.
Applications in writing, together with full CV to David Wilson at email@example.com
Application deadline is Friday 27th February
Date Posted: 12 February 2015