Regulatory Affairs Project Manager- Medical Devices
We are searching for an experienced medical device Regulatory Affairs professional to work as a Project Manager to play a lead role within a team of 6 for international submissions.
You will be joining a globally recognised medical device company who are highly regarded as a true market leader in their areas of specialism.
For the incoming regulatory affairs person, this is an exciting time to join and contribute at a key time of growth for the business with increased manufacturing and a big push on new product development for their already varied product portfolio.
This Regulatory Affairs position is responsible for managing all facets of regulatory strategy to market, developing regulatory submissions, managing departmental projects.
Duties and Responsibilities:
" Manage the full US FDA regulatory submission process i.e. (510(k), PMA) routes to market.
" For EU and International Registrations- manage the development of design dossiers or technical files for registration of products (Class lll, lla and llb).
" Provides regulatory direction to development project teams as a core team member, or lead a project team; develops and communicates regulatory strategy for new products.
" Responsibility for oversight and prioritization of departmental tasks and projects.
" Bachelor's degree in Life Sciences, Engineering or related field
" A minimum of 5 years of experience in Regulatory Affairs, preferably class III devices and exposure to US FDA submissions.
" Regulatory Affairs Certification (US or EU) preferred.
" Combination of education and experience may be considered
If you are looking for an opportunity to shape strategy at the top level but also to build systems from the ground up at a pivotal time in company's history this could be the role for you.
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.