Regulatory Affairs Associate
*Premarket focus - product developments and changes across European and USA markets
Regulatory Affairs Associate - Medical Devices * Premarket focus - product developments and changes across European and USA markets* Cheshire Location, with flexibility on remote working* Highly competitive salary. Further Benefits: Bonus, Private Healthcare, Health insurance, Pension, BonusEstablished group of companies, specialising in the design, development, manufacture and distribution of high performing medical devices, spanning wound care through to advanced surgical technologies. Global reach, with a strong pipeline in research stages.OpportunityReporting to the Regulatory Affairs Manager, your focus will lie in premarket regulation for wound care products.Responsibilities * Maintain the Pre-Market and Product Life Cycle processes and SOPs* Prepare documentation for submissions of new product developments and changes to existing devices for Europe and USA.* Contribute to regulatory strategy planning and change management for the European and USA markets* Review and approval of key compliance records e.g. labelling, Instructions for Use (IFU).* Ensure all Regulatory Technical Documentation is in compliance with 93/42/EEC (MDD), 2017/745 (MDR) and 21 CFR Part 820* Contribute to regulatory strategy planning and change management for the European and USA markets* Maintain exceptional internal relationships from research through to product launch to ensure European and USA regulatory requirements are met.* Strong external communications with Regulatory Authorities, Auditors, Customers globally* Pre-Market and Product Life Cycle Subject Matter Expert for the purpose of audits, inspections, and submission of QA management system changes * Maintain a working knowledge of any changes in regulatory review globally, implementing updatesSkills and Experience * Tertiary qualification in Life Sciences, or equivalent industry experience * Understanding of Risk Management within a Medical Device industry* Knowledge of relevant GMP and Quality Systems standard, specifically with FDA Quality System Regulation and ISO 13485 * Understanding of the European Medical Devices Regulation (MDR) Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.
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