Position: Regulatory Affairs Associate \n Location: Gloucester\n Job Type: Permanent / Onsite (Hybrid)\n\nOur client, a global leading manufacturing business based in Gloucester are on the hunt for a detailed and organised Regulatory Affairs Associate!\n\nRole and Responsibilities – Regulatory Affairs Associate\n In this role, your key responsibility is to maintain regulatory compliance, obligations to international regulations and organisation of related technical documentation.\n\nOther responsibilities include:\n\nEnsure documentation aligns with ISO 13485, ISO 14971 and where applicable IEC (phone number removed)\nSupport preparation, review, and maintenance of Technical Documentation, including device description, GSPR, risk management, clinical evaluation, PMS, PMCF, and labelling.\nPartner with R&I, Engineering, Quality, Manufacturing, Sales and Supply Chain to ensure regulatory deliverables are embedded and on time\nSupport international registrations (e.g., FDA listing support, Canada, Australia) as business needs evolve.\nExperience or Qualifications – Regulatory Affairs Associate\n\nProven experience in a medical device regulatory / quality role\nSounds understanding of regulatory processes within med devices standards (ISO 13485, MDR, FDA 21 CFR Part 280)\nInternal QMS auditing experience\nAbility to prioritise and deliver to deadlines in a regulated environment.\nCandidates who currently are a Regulatory Affairs Associate, Regulatory Affairs Engineer, Regulatory Affairs Specialist or Quality & Regulatory Associate may be suitable for this position.\n\nFor more information regarding this Regulatory Affairs Associate role please contact Ben Herd on (phone number removed) or \n\nOmega Resource Group is acting as an Employment Agency in relation to this vacancy.\n\nOmega Resource Group is an employment agency specialising in opportunities at all levels within the Engineering, Aerospace, Automotive, Electronics, Defence, Scientific, Oil & Gas, Construction and Manufacturing sectors.\n\nFor details of other opportunities available within your chosen field please visit our website \n\nOmega is an employment agency specialising in opportunities at all levels within the Engineering, Manufacturing, Aerospace, Automotive, Electronics, Defence, Scientific, Energy & Renewables and Tech sectors