Job Title

Senior Post Market Surveillance Specialist Contract: 12 monthsStart: ASAPLocation: Fully remote (UK)PAYE: 153 per dayUmbrella: 207 per dayHave you got what it takes to succeed The following information should be read carefully by all candidates.The RoleWere looking for an experienced Senior Post Market Surveillance Specialist to support global postmarket surveillance activities within a regulated medical device environment. This is a handson contract role focused on executing postmarket surveillance plans, analysing complex datasets, and ensuring ongoing compliance with global regulatory requirements.Youll play a key role in maintaining high standards of product quality and patient safety, working closely with crossfunctional teams across Quality, Regulatory, R&D, Operations and Clinical.Key ResponsibilitiesPost Market SurveillanceExecute postmarket surveillance processes in line with regulatory and internal requirementsEstablish, maintain and update Post Market Surveillance PlansCompile and facilitate PostMarket Surveillance and PSUR reportsAnalyse complaint and product performance data, identifying trends and escalation risksMaintain product malfunction codes and support complaint escalation reviewsPresent timely and accurate complaint and surveillance insights to stakeholdersSupport investigations, risk reviews and trending activities across product portfoliosRisk, Design & DevelopmentMaintain a strong understanding of product risk profiles, including reportable harms and malfunctionsProvide quality and compliance input into risk management and design control activitiesSupport failure mode identification and risk assessments for new and existing productsQuality Management & ComplianceOperate in full compliance with the Quality Management SystemSupport CAPA, complaint investigations, health hazard evaluations, and audit activitiesAct as an SME during internal and external auditsContribute postmarket surveillance input to management review materialsDrive continuous improvement of postmarket surveillance processes, tools and reportingSkills & ExperienceEssentialStrong background in Post Market Surveillance within medical devices or life sciences xjdpvnf Indepth knowledge of global regulations and standards including MDR (EU 2017/745), 21 CFR 820, ISO 13485 and ISO 14971Excellent data analysis capability with advanced MS Excel (pivot tables, VLOOKUPs, formulas, charts)Strong proficiency in MinitabExcellent written and verbal communication skillsAbility to manage multiple priorities in a fastpaced, regulated environmentDesirableSix Sigma Green or Black BeltStatistical Analysis certificationQualificationsBSc (or equivalent experience) in a scientific or technical disciplineMinimum 5 years experience in a quality engineering or postmarket surveillance roleExperience across the product lifecycle, including risk management and postmarket activities