Senior Regulatory Affairs Specialist - Medical Device - LondonSRG are currently working with a Global Medical Device company who are looking for a Senior Regulatory Affairs Specialist to join their team on a permanent basis at a competitive salary and benefits package, depending on experience.Reporting to the RA Manager, you will responsible for ensuring the operations effectiveness of RA activities throughout the organisation.Key tasks Deputise for Regulatory Affairs and Compliance department in the absence of reporting Manager as required. Maintenance and implementation of policies and procedures. Tracking regulatory changes (standards/directives/guidance documents) and managing the initiation of applicable updates to relevant processes. Dissemination of the regulatory changes throughout the organisation. Contact as appropriate with regulatory authorities. Coordinate and manage regulatory projects as required. Review change documentation for regulatory impacts. Review and approve labeling, marketing literature and claims substantiation compliance. Working closely with the NPI / R&D team, to lead regulatory input in assigned R&D projects and pre-launch reviews (project management and member of teams). Preparation and maintenance of Technical Files & associated documentation, (e.g. 510(k)s and notes to file.) Support and coordinate the risk evaluation activities. Support and coordinate field correction process as required. Mentor and develop other members of staff in Regulatory and Compliance requirements. To operate as a member of the RA team with a mandate to promote regulatory sound business practices throughout the organisation. Ensure compliance to all processes related to the requriements of Regulatory Affiars department. Working with the relevant department to ensure the maintenance of Technical Files, Device master files & associated documentation, Working with program teams in identifying regulatory requirements early in the new product development process. Participates as a member of a product development team to provide regulatory support to the project. Ensuring that they meet the regulatory requirements of the target markets Maintain an up to date awareness of regulatory issues and expectations of EMA, FDA, and other global regions as required. Process changes to regulations as applicable. Any other tasks that sits outside your current role from time to time to support the activities of the business.Qualifications, skills and desirable experience You will have an Engineering Degree or equivalent experience. You will have experience working in a regulated environment preferably with medical devices. Knowledge of the Medical Devices Directive 93/42/EEC is essential; knowledge of FDA QSR regulations would be desirable.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.