Regulatory Affairs Specialist- Medical Devices
We are searching for an experienced medical device Regulatory Affairs professional to play a key role in the ongoing growth of the business, leading on EU regulatory product submissions and registrations to regulatory agencies.
You will be joining a company with global reach with sites in numerous continents and countries and who have doubled in size in the past couple of years alone. Furthermore, this is an exciting time to join with an increased focus on new product introduction / NPI and registrations in new international markets.
For the incoming regulatory affairs person, you will be responsible for all facets of regulatory strategy to market from end to end.
Regulatory Affairs Responsibilities:
" Regulatory Affairs for EU sites on product life-cycle development teams to ensure regulatory objectives are achieved throughout the development process.
" Maintain design history files.
" Create and maintain Technical Files (EU). Audit changes to technical files.
" Complete submissions to EU and FDA authorities.
" Lead on the timely renewals of certificates, licenses and registrations.
" Review of customer complaints and define their report-ability as per post market surveillance activities.
" Maintain your current knowledge of MDD and FDA.
" Circa 5 years' relevant experience within medical device' regulatory affairs.
" Good working knowledge of regulations, quality systems and guidelines: CE Mark; Medical Device Directive / MDD MDR ; ISO 13485; ISO 14971; 21 CFR 820 US FDA requirements.
If you are looking for an opportunity to play a lead role in a Regulatory team within a growing business that provides a flexible approach to your work and career development get in touch with interviews available immediately.
Please send your CV and contact James Powell of TXM Recruit.
("Regulatory affairs" OR "ce mark" OR "ce marking" OR "technical files" OR "design dossier" OR 93/42 OR mdd)
TXM Recruit is an equal opportunities employer. If you have any specific requirements or require assistance or reasonable adjustments to be made for you during the selection process due to disability or long-term health condition, we will do our best to assist you.