Regulatory Affairs Manager Medical Device London £60,000 £65,000 per annum + 15-20% Bonus & BenefitsSRG are currently recruiting for a Regulatory Affairs Manager to join...
Regulatory Affairs Manager - Medical Device - London - £60,000 - £65,000 per annum + 15-20% Bonus & BenefitsSRG are currently recruiting for a Regulatory Affairs Manager to join a Medical Device company in London on a permanent basis at a competitive salary and benefits package, depending on experience.Working in a close knit team, this position is of key importance is ensuring that the firm's aggressive expansion plans (both geographically and from a product portfolio perspective) are supported. Consequently the successful applicant must see themselves as a service to the sales and product development teams. The firm is fast-moving and dynamic and so the successful applicant should expect to be not only a high-quality individual but will also need to be a clear and confident communicator.Experience and Qualifications required:* Experience or workgin in a Regulatoyr Affairs Manager or Senior Reg Affairs specialist role. Of this period, at least 3 years must have been in a Senior RA Specialist role. Experience with active medical devices for some of this period is a must. A senior RA role would be characterised by the person creating/driving key documents rather than just doing submissions with docs created by others AND/OR performing or driving the review of regulatory requirements (Directives, Regulations, Guidance or Standards) and producing/effecting solutions to those requirements.
* A demonstrable understanding of IEC14971, risk control techniques and IEC62366. Experience or knowledge or understanding of IEC60601-1 or IEC62304 is preferable but not a must-have.
* Demonstrable experience and understanding of the MDD, FDA 510(k) process and product registration. The colleague must have managed CE marking of at least one active product. Experience with submitting a 510(k) (for any type of device) is highly desirable but is not a must-have.* Experience or understanding of complaints and vigilance requirements in Europe and America. Experience of handling a recall will be a plus.* Demonstrable experience in at least four of the following topics: verification testing, validation, technical files, labelling content and controls, software compliance, cyber-security, clinical evaluation reports, post-market surveillance, post-market clinical follow-up, manufacturing process validation. Skills required:* Excellent written English, excellent written and oral presentation, good analytical approach to planning and problem solving. Qualifications:* Degree or equivalent qualification in a science or technical subject (electronics or engineering preferred). Skills rqd: * Demonstrable excellent written competence with Word and excellent command of written English. Good eye for detail, ability to multi task, ability to prioritise and escalate when priority conflicts occur. For more information, please call Laith Mustafa on 0161 868 2231 or email
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.