Position: Entry level
Job type: Full-time
Job content
VQ Life Sciences are recruiting for a Regulatory Affairs Assistant/Specialist with Medical Device experience on a 12 month FTC. This is for someone based around the Derbyshire area. Department: Regulatory Affairs Reports To: Head of Regulatory Affairs Role Purpose To assist the Head of Regulatory Affairs in ensuring that the appropriate licensing, marketing and legal compliance of a range of medical devices and systems either manufactured or distributed by the company order to control their safety and efficacy. Key ResponsibilitiesCompile Technical File/Documentation for class I and class IIa/IIb products in accordance with the MDR 2017/745 requirements.Product registration activities with EUDAMED and MHRAAssist in compiling Design History File (DHF) and update product risk management files in accordance with ISO 14971.Assist in the planning, preparation and submission of regulatory agency applications, reports, or correspondence.Assist in the companies’ post market, vigilance and recall activities in accordance with MDR 2017/745 and MDCG guidance. Vigilance and complaint reporting to regulatory authorities.Review and approve labelling in accordance with General Safety and Performance (GSPR) requirementsUpdate Clinical Evaluation Report in accordance with MDR/MDCG guidance.Assist in providing responses to regulatory agencies regarding product information or issues.Assist with staff training in regulatory policies or procedures.Assist with audits, regulatory agency inspections, or product recalls.Compile regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards, including reviewing materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.Maintain effective communication and working relationships between Reg. Affairs and other departments.Completion of customer regulatory affairs questionnaires. Relationships/Contacts Internal departments (Quality / Manufacturing / Warehouse / Customer Service/ Sales) External suppliers, External customers and Notified Bodies Other Requirements Any other reasonable duties, as requested by your Manager, to meet the changing needs of the business. PERSON PROFILE Experience, Qualifications and Role Specific Skills Essential Degree qualification (or equivalent experience in Regulatory Affairs) Preferable Degree in medical science, with relevant course studies such as biochemistry, biology, biomedical science, biotechnology, chemical and physical sciences, chemistry, life sciences, medicine, pharmacology and pharmacy. Work Experience Essential2+ Years experience in Regulatory AffairsTechnical File/Technical Documentation creationMDD or MDR experienceISO 13485:2016 experience and Medical device industry experienceKnowledge and experience in Design History File and Technically astute Preferable LEAN manufacturing experience, Good interpretation skills of data using statistics, Experience in plastics processing and Experience of custom procedure pack controls Professional Skills EssentialUnderstanding of both legal and scientific matters and Awareness of legislation governing the approval of productsAbility to grasp new concepts quickly and to assimilate and evaluate scientific dataAbility to work under pressure and to tight deadlinesTechnical report writing skills and Project management skillsCompetent in Microsoft Office, using databases and familiarity with commercial softwareAnalytical and problem-solving skills and Positive communicator (oral and written)Results Oriented and Team working skillsService Oriented (internal and external customers)Integrity and professional approach to workConscientious, reliable and Good organisational skillsTact and diplomacy and Ability to adapt to changing requirements and prioritiesExcellent attention to detail and Culturally aware Preferable Strong negotiation skills, Effective training and presentation skills, Fluency in other European language helpful and Ambitious. If you’re a Regulatory Affairs professional interested in a FTC position and have experience with Class I, Class IIa and IIb Medical Devices, please get in touch
Deadline: 21-06-2024
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