A superb opportunity has arisen for an experience Regulatory Affairs Manager from the medical device industry to take up a fantastic new position with a Global Leading Organisation. You will be managing a relatively large team of 5 Regulatory Affairs Professionals of varying seniority.
The Regulatory Affairs Manager will be responsible for production and review of Design Dossiers, Technical Files, and Device Master Files. Preparation of regulatory submissions for global product registrations / approvals including the FDA. Communicating and negotiating with outside agencies / regulatory bodies. Update and review of IFUs, Packaging, Labelling & Marketing Literature. Product post market surveillance oversight. Development and implementation of the regulatory database to improve and streamline current practices. Oversee day-to-day actions of the RA department personnel based on departmental requirements.
The successful candidate will have significant Regulatory Affairs experience from the medical device industry. As such you will be degree educated and have detailed knowledge on medical device regulations and the Medical Device Directive 93/42/EEC and other applicable global regulations including FDA 510(k) submissions, PMA and IDE.
Please apply online or for more information please call Paul on 0141 332 9060 or send an email to paul.rees@srg.co.uk
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency.
SRG, winners of the Recruitment Professional Awards 2011 'Best Company to work for' and 'Best People Development Business' awards, and the only "highly commended" company in the Annual Recruiter Awards for Excellence 2011, for 'Best Small Recruitment Agency to Work For'.