[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"vacancy-senior-industry-success-consultant-medical-device-regulation-88820":3},{"statusCode":4,"vacancy":5,"roleSummary":28,"metaData":37,"schemaJobPosting":41,"vacancyBannerPath":55,"previousPagePath":26,"referralPagePath":56,"saveFormRoute":57,"loginPath":58,"isPmVacancy":25,"isBaVacancy":25,"webConfiguration":59,"vacancySource":63,"maxFileSize":75,"metaImg":76,"captchaSiteKey":77,"linkedinConfig":78,"languages":82},200,{"id":6,"name":7,"crmId":8,"description":9,"shownOnSiteEqualOpportunityEmployerDescription":10,"equalOpportunityEmployerDescription":11,"direction":12,"level":13,"city":16,"referralProgram":10,"linkedinTags":18,"tags":21,"shownOnSiteLeadershipDescription":25,"leadershipDescription":26,"shownOnSiteWeOffer":10,"weOfferDescription":27},88820,"Senior Industry Success Consultant (Medical Device Regulation)",101214,"\u003Ch2>ABOUT THE ROLE\u003C\u002Fh2>\u003Cp>In this role, you will act as a Medical Device Regulatory SME, supporting client engagements across the medical device product lifecycle. Working within SoftServe’s HCLS Business Consulting Group, you will connect deep regulatory knowledge with SoftServe’s digital capabilities to help medtech and life sciences organizations navigate complex compliance challenges and reduce time-to-market.\u003C\u002Fp>\u003Ch2>RESPONSIBILITIES\u003C\u002Fh2>\u003Cul>\u003Cli>Advise clients on device classification\u003Cstrong>, \u003C\u002Fstrong>regulatory strategy, and submission preparation (510(k), PMA, De Novo, or equivalent), identifying the most efficient pathway based on device type, intended use, and risk profile\u003C\u002Fli>\u003Cli>Advise on post-market surveillance obligations, including MDR\u002FMDV reporting requirements, complaint handling processes, and corrective action frameworks\u003C\u002Fli>\u003Cli>Provide guidance on software as a medical device (SaMD)\u003Cstrong> \u003C\u002Fstrong>and digital health regulatory considerations, including FDA’s software guidance frameworks and risk-based classification approaches\u003C\u002Fli>\u003Cli>Review and validate documented requirements to ensure alignment with applicable regulatory standards, design controls, quality system requirements, and the client’s operating model\u003C\u002Fli>\u003Cli>Provide guidance to delivery teams on regulatory context and compliance requirements to ensure solutions are fit for purpose in regulated environments\u003C\u002Fli>\u003Cli>Conduct stakeholder interviews, workshops, and process discovery to capture current regulatory practices, identify gaps, and understand clients’ compliance challenges and operational objectives\u003C\u002Fli>\u003Cli>Perform industry-focused research and analysis to support regulatory strategy, solution shaping, and client decision-making across the product development and approval lifecycle\u003C\u002Fli>\u003Cli>Support creation of client deliverables including regulatory assessments, gap analyses, compliance roadmaps, playbooks, and Points of View (POVs)\u003C\u002Fli>\u003Cli>Support RFP\u002FRFI responses and pre-sales proposals by contributing regulatory domain expertise and shaping solution narratives relevant to medtech clients\u003C\u002Fli>\u003Cli>Build trust-based relationships with client stakeholders; collect and evaluate feedback on implemented solutions to identify risks, improvements, and additional service opportunities\u003C\u002Fli>\u003C\u002Ful>\u003Ch2>REQUIREMENTS\u003C\u002Fh2>\u003Cul>\u003Cli>5-7 years of experience with a direct focus on medical device regulatory affairs, quality, or compliance.\u003C\u002Fli>\u003Cli>Hands-on experience with medical device regulatory processes, including device classification, pre-submission activities, technical documentation, and submission preparation for FDA (510(k), PMA, De Novo)\u003C\u002Fli>\u003Cli>Working knowledge of design controls, quality system requirements, and post-market surveillance obligations applicable to medical device development and commercialization\u003C\u002Fli>\u003Cli>Familiarity with SaMD and digital health regulatory frameworks\u003C\u002Fli>\u003Cli>Experience with process analysis, structured problem-solving, and creation of requirements specifications or regulatory deliverables\u003C\u002Fli>\u003Cli>Ability to translate complex regulatory requirements into actionable recommendations for both technical and business audiences\u003C\u002Fli>\u003Cli>Excellent communication, presentation, and facilitation skills\u003C\u002Fli>\u003C\u002Ful>",true,"\u003Cp style=\"text-align: justify;\">\u003Cem>SoftServe is an equal opportunity employer. Qualified applicants will receive consideration regardless of race, color, ancestry, ethnicity, national origin, religion, sex, sexual orientation, gender identity or expression, age, citizenship, disability, health condition, marital or family status, veteran status, or any other characteristic protected by applicable law.\u003C\u002Fem>\u003C\u002Fp>","Digital Consultancy",{"id":14,"name":15},5,"Manager",[17],"USA",[19,20],"#LI-DNI","#LI-Remote",[22],{"id":23,"name":24},"remote","Remote\u002FOffice",false,null,"\u003Cdiv class=\"wrapper\">\n    \u003Csection class=\"section-about-us\">\n        \u003Cdiv class=\"about-us\">\n            \u003Cdiv class=\"about-us__content\">\n                \u003Cdiv class=\"about-us__text\">\n                    \u003Ch2>About us\u003C\u002Fh2>\n                    \u003Cp>\n                        We are a digital engineering and technology consulting company where expertise grows alongside\n                        people. For more than 30\n                        years, we have been elevating technology: helping organizations navigate complex business\n                        challenges by combining deep\n                        engineering knowledge with thoughtful, research-backed innovation. Our teams work across key\n                        areas: digital\n                        engineering, data and analytics, Сloud, and AI\u002FML. In each, we deliver practical, scalable\n                        solutions rooted in real\n                        business needs and measurable human impact.\n                    \u003C\u002Fp>\n                    \u003Cp>\n                        You bring your perspective and ambition. We create an environment where your work meets\n                        clarity, confidence, and\n                        purpose.\n                    \u003C\u002Fp>\n                \u003C\u002Fdiv>\n\n                \u003Cdiv class=\"about-us__image\">\n                    \u003Cpicture>\n                        \u003Csource media=\"(min-width: 1025px)\" srcset=\"\u002Fimages\u002Fvacancy\u002Fdesctop-about.webp\" \u002F>\n                        \u003Csource media=\"(min-width: 769px)\" srcset=\"\u002Fimages\u002Fvacancy\u002Ftablet-about.webp\" \u002F>\n                        \u003Cimg src=\"\u002Fimages\u002Fvacancy\u002Fmobile-about.webp\" alt=\"About us\" loading=\"lazy\" \u002F>\n                    \u003C\u002Fpicture>\n                \u003C\u002Fdiv>\n            \u003C\u002Fdiv>\n        \u003C\u002Fdiv>\n\n        \u003Cdiv class=\"we-offer\">\n            \u003Ch2>We offer\u003C\u002Fh2>\n\n            \u003Cdiv class=\"we-offer__list\">\n\n                \u003Carticle class=\"offer-card offer-card--peach\">\n                    \u003Cspan class=\"offer-card__graphic offer-card__graphic--compensation\" aria-hidden=\"true\">\u003C\u002Fspan>\n\n                    \u003Cdiv class=\"offer-card__inner\">\n                        \u003Cdiv class=\"offer-card__title-wrap\">\n                            \u003Ch3 class=\"offer-card__title\">Flexible Work Model\u003C\u002Fh3>\n                        \u003C\u002Fdiv>\n\n                        \u003Cdiv class=\"offer-card__text-wrap\">\n                            \u003Cp class=\"offer-card__text\">\n                                Work from home, from the office, or in a hybrid format that supports focus and\n                                collaboration.\n                            \u003C\u002Fp>\n                        \u003C\u002Fdiv>\n\n                        \u003Cspan class=\"offer-card__icon\" aria-hidden=\"true\">\n                            \u003Cspan class=\"offer-card__icon-circle\">\u003C\u002Fspan>\n                            \u003Cspan class=\"offer-card__icon-line offer-card__icon-line--horizontal\">\u003C\u002Fspan>\n                            \u003Cspan class=\"offer-card__icon-line offer-card__icon-line--vertical\">\u003C\u002Fspan>\n                        \u003C\u002Fspan>\n                    \u003C\u002Fdiv>\n                \u003C\u002Farticle>\n\n                \u003Carticle class=\"offer-card offer-card--blue\">\n                    \u003Cspan class=\"offer-card__graphic offer-card__graphic--communities\" aria-hidden=\"true\">\u003C\u002Fspan>\n\n                    \u003Cdiv class=\"offer-card__inner\">\n                        \u003Cdiv class=\"offer-card__title-wrap\">\n                            \u003Ch3 class=\"offer-card__title\">Compensation & Benefits\u003C\u002Fh3>\n                        \u003C\u002Fdiv>\n\n                        \u003Cdiv class=\"offer-card__text-wrap\">\n                            \u003Cp class=\"offer-card__text\">Competitive, market-based pay, benchmarked by role and\n                                location — plus health coverage, paid time off, wellness support, and learning\n                                opportunities.\u003C\u002Fp>\n                        \u003C\u002Fdiv>\n\n                        \u003Cspan class=\"offer-card__icon\" aria-hidden=\"true\">\n                            \u003Cspan class=\"offer-card__icon-circle\">\u003C\u002Fspan>\n                            \u003Cspan class=\"offer-card__icon-line offer-card__icon-line--horizontal\">\u003C\u002Fspan>\n                            \u003Cspan class=\"offer-card__icon-line offer-card__icon-line--vertical\">\u003C\u002Fspan>\n                        \u003C\u002Fspan>\n                    \u003C\u002Fdiv>\n                \u003C\u002Farticle>\n\n                \u003Carticle class=\"offer-card offer-card--peach\">\n                    \u003Cspan class=\"offer-card__graphic offer-card__graphic--flexible\" aria-hidden=\"true\">\u003C\u002Fspan>\n\n                    \u003Cdiv class=\"offer-card__inner\">\n                        \u003Cdiv class=\"offer-card__title-wrap\">\n                            \u003Ch3 class=\"offer-card__title\">People-first Leadership\u003C\u002Fh3>\n                        \u003C\u002Fdiv>\n\n                        \u003Cdiv class=\"offer-card__text-wrap\">\n                            \u003Cp class=\"offer-card__text\">\n                                Approachable leaders who communicate openly, keep teams close to the strategy, and\n                                support long-term planning.\n                            \u003C\u002Fp>\n                        \u003C\u002Fdiv>\n\n                        \u003Cspan class=\"offer-card__icon\" aria-hidden=\"true\">\n                            \u003Cspan class=\"offer-card__icon-circle\">\u003C\u002Fspan>\n                            \u003Cspan class=\"offer-card__icon-line offer-card__icon-line--horizontal\">\u003C\u002Fspan>\n                            \u003Cspan class=\"offer-card__icon-line offer-card__icon-line--vertical\">\u003C\u002Fspan>\n                        \u003C\u002Fspan>\n                    \u003C\u002Fdiv>\n                \u003C\u002Farticle>\n\n                \u003Carticle class=\"offer-card offer-card--blue\">\n                    \u003Cspan class=\"offer-card__graphic offer-card__graphic--leadership\" aria-hidden=\"true\">\u003C\u002Fspan>\n\n                    \u003Cdiv class=\"offer-card__inner\">\n                        \u003Cdiv class=\"offer-card__title-wrap\">\n                            \u003Ch3 class=\"offer-card__title\">Advanced tech communities\u003C\u002Fh3>\n                        \u003C\u002Fdiv>\n\n                        \u003Cdiv class=\"offer-card__text-wrap\">\n                            \u003Cp class=\"offer-card__text\">Stay close to AI\u002FML, Cloud, Quantum Computing, IoT, and\n                                Robotics communities, with projects built on modern frameworks.\u003C\u002Fp>\n                        \u003C\u002Fdiv>\n\n                        \u003Cspan class=\"offer-card__icon\" aria-hidden=\"true\">\n                            \u003Cspan class=\"offer-card__icon-circle\">\u003C\u002Fspan>\n                            \u003Cspan class=\"offer-card__icon-line offer-card__icon-line--horizontal\">\u003C\u002Fspan>\n                            \u003Cspan class=\"offer-card__icon-line offer-card__icon-line--vertical\">\u003C\u002Fspan>\n                        \u003C\u002Fspan>\n                    \u003C\u002Fdiv>\n                \u003C\u002Farticle>\n            \u003C\u002Fdiv>\n        \u003C\u002Fdiv>\n    \u003C\u002Fsection>\n\u003C\u002Fdiv>",{"location":29,"workType":30,"direction":12,"techLevel":15,"techLevelId":14,"personalRecruiter":32,"subdirection":36},[17],[31],{"id":23,"name":24},{"fullName":33,"email":34,"profileImgPath":35},"Christina 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Join the IT global community. On freelance or full-time, remote or in the office. Apply for your dream job at SoftServe.","https:\u002F\u002Fcareer.softserveinc.com\u002Fvacancy\u002Fsenior-industry-success-consultant-medical-device-regulation-88820",{"@context":42,"@type":43,"title":7,"description":44,"datePosted":45,"applicantLocationRequirements":46,"jobLocationType":48,"employmentType":49,"hiringOrganization":50},"https:\u002F\u002Fschema.org\u002F","JobPosting","SoftServe is people-first. People who build a global IT company and make it grow. 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