* Work with pioneering medical devices in the mental health field * Benefit from an experienced team, boasting longevity and achievable progression
SRG partner with a leading supplier of alternative mental health therapy. Their devices are unique - offering a non-invasive treatment that is proven to combat depression amongst other common mental health illnesses. They have a global reach with their products, with further growth plans in place.
As Regulatory Affairs Specialist, you will assist with the management of regulatory projects, including new product development, product life cycle and regulatory processes. There will be a focus on developing premarket submissions / design dossiers for products intended to be marketed in the US and Canada.
RESPONSIBILITIES* To prepare, submit and facilitate Class 11 510(k) submissions in accordance with the FDA's Code of Federal Regulations* To prepare, submit and facilitate Class 11 and Class 111 Helath Canada Submissions * Lead, Manage, schedule and prepare Clinical Evaluation Reports (CER) in accordance with regulatory guidelines and Company Quality Procedures.* Managing, scheduling, and preparing Post Market Surveillance (PMS) Reports in accordance with regulatory guidelines and Company Quality Procedures and to be the main point of contact for all PMS activities including Post Market Clinical Follow-up (PMCF).* Data analysis, identifying trends and reporting of PMS findings, interacting with other departments on PMS related activities.* Identifying, reporting and co-ordination of adverse events, field safety notices (FSN) and product recalls to the local Health Authorities according to the national regulations and answer any subsequent questions.* Update Risk Management Reports, CER and Product Technical Files based on findings of PMS, Adverse Events, FSN and Product Recalls in line with internal procedures.* Preparing and maintaining Technical Files in line with the requirements of 93/42/EEC and Company Quality Procedures.* To offer general advice on regulatory strategy for new product developments, product re-development and process changes. * Review and approve marketing literature and product operating manuals to ensure the content meets the Regulatory Requirements for the target country.* Monitor changes in Legislation, Standards and Guidance Documents.* To contribute to the development and implementation of regulatory policies, procedures and specifications across the company and ensuring that these are compliant with the Quality Management System.
EXPERIENCE/SKILLS* Previous experience with Global Medical Vigilance Requirements.* Previous experience with Post Market Surveillance Activities.* Experience operating in an ISO 13485 and 21 CFR.820 certified Quality Management System.* Knowledge of 93/42/EEC Medical Devices Directive.* Knowledge of ISO 13485 and 21 CFR 820, Quality Management Systems.* Knowledge of MEDDEV 2.7/1, MEDDEV 2.12/2, 21 CFR 803.* Knowledge of ISO 14971 (Risk Management of Medical Devices).
For more information, or to discuss your career in the Quality Assurance/Regulatory Affairs arena, please contact Holly Evans on email@example.com
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