Regulatory Affairs and Compliance Specialist

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Regulatory Affairs and Compliance Specialist, Regulatory Affairs, Compliance Specialist, FMEA, R&D, ROLE AND RESPONSIBILITIES TO TAKE A PROJECT LEADING ROLE IN BRINGING MEDICAL PROJECTS FROM CONCEPT/ DESIGN STAGE, THROUGH REGULATORY APPROVALS, AND IN TO COMMERCIAL PRODUCTS. Regulatory Affairs and Compliance Specialist is required by manufacturer of medical devices ranging from Class 1 through to Class III that are used within a wide range of interesting and challenging medical fields based in Suffolk. Due to current growth a Regulatory Affairs and Compliance Specialist is needed to add additional depth and expertise within the Medical Device Regulatory Affairs Department. The basis of the job role: Assist the R&D team in the formation of design assurance documentation, and support the team with the current regulatory information required for new and innovative medical device designs Participate in all types of design and development team reviews including leading Risk Management and FMEA activities Preparing document packages for regulatory submissions and communicate with relevant regulatory authorities globally and within the EU. Assisting with Clinical Evaluation, Post Market Surveillance and Vigilance activities with devices on the market. Efficient administration and management of regulatory technical documentation. Keeping up to date with regulatory procedures and changes and providing general advice on regulatory strategy for new product developments, product improvements and process changes. Contribute to the development and improvement of regulatory policies and procedures across the organization and ensure compliance with the company Quality Management System. Attend occasional off site meetings, events and consultations with a broad range of project stakeholders including medical professionals. QUALIFICATIONS AND REQUIREMENTS Minimum of 2 years' experience in a Regulatory Affairs role for a Medical Device Manufacturer. A degree or higher in a relevant life science, scientific or engineering-based discipline is preferable, but a combination of education and experience may be considered. As such, Regulatory affairs experience working within a medical devices organization, or R&D team, may be considered equal to a high level of education. An employment history within technical, design, product development or any form of practical experience would be an advantage EU 2017/745 MDR knowledge and related Technical Documentation Experience working within an ISO (phone number removed) QMS system. An in depth knowledge of ISO 13485 Design and Development Assurance Principles In depth knowledge of ISO 14971 preferred. Experience gained working in a Class I, IIa / IIb or Class III Medical device regulatory environment. An in-depth knowledge and appreciation of the regulatory requirements for placing medical devices on European and selected global markets. Knowledge of MDGC, MEDDEV and MHRA guidance and experience with FDA regulatory framework would be preferable. Must be computer literate and have a very good written & verbal use of English language. Occasional worldwide and national travel may be required. A methodical thinker, capable of making rational judgments from available information and meeting targets in agreed timescales. Ability to communicate with all levels of the organization along with medical professionals and regulatory and notified bodies. A hands-on mentality is required. Additional training may be available as part of a continual personal and departmental development programme. This role is an ideal opportunity for personal growth while working on a number of new, varied and interesting projects, which will provide a high level of job satisfaction, through various problem solving challenges. Vacancy Information: Location: Mildenhall, Suffolk Salary range: Dependent on Experience Job type: Permanent Experience: 2 years Job Section: Regulatory (Medical) Working Hours: Monday - Friday (full-time) Reference: AB85 Contact: Alison Bradley About Klein Hamilton Recruitment Klein Hamilton are Legal & IT Securities specialist Recruiters, working with magic circle, silver circle, blue chip, fintech and dynamic SME businesses, who trust us in finding them the best talent. You can apply for our vacancies in confidence. We are a regulated employment agency and will discuss this vacancy with you and gain your permission prior to submission of application directly to the decision maker. REFER AND EARN Apply today to be considered for this opportunity. Should your application match the requirements, one of our consultants will be in touch to discuss the vacancy in detail prior to sending your CV to the client. Also, refer a friend or colleague to us and receive up to £1,000 should we successfully assist them in securing a new job Regulatory Affairs and Compliance Specialist, Regulatory Affairs, Compliance Specialist, FMEA, R&D

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