{"id":52234,"title":"Director, Regulatory Affairs (f/m/d)","company":"eResearchTechnology GmbH","city":"Estenfeld","region":"Bayern","location":"97230 Estenfeld","work_model":"hybrid","employment_type":"full_time","employment":["full_time"],"roles":["leadership"],"visa":"not_mentioned","relocation":"not_mentioned","posted_at":"2026-10-28T00:00:00+00:00","tools":["R","Agile","Google Cloud"],"seniority":"lead","years_experience_min":6,"german_requirement":"required","german_level":"unspecified","english_requirement":"required","english_level":"unspecified","team_language":"unknown","confidence":0.9,"method":"rules","language_badge":"German required","language_evidence":"Fluency in English and German","requirements_snippet":null,"url":"https://www.arbeitsagentur.de/jobsuche/jobdetail/12513-0007660526-S","source":"bundesagentur","agency":null,"description_text":"DIRECTOR, REGULATORY AFFAIRS (F/M/D)\n\nJoin Clario, part of Thermo Fisher Scientific, as an Engineer, R&D Software Engineering (f/m/d) in Estenfeld and help develop innovative software solutions that support clinical research and accelerate the delivery of life-changing therapies to patients worldwide. In this role, you'll contribute to the design, development, testing, and continuous improvement of software products while working closely with cross-functional teams in an agile environment. Your work will directly impact the quality, reliability, and performance of technologies used across global clinical trials.\n\nWHAT WE OFFER\n\n*\nCompetitive compensation.\n\n*\nFlexible working hours and working time accounts to support the work-life balance.\n\n*\nHybrid work model, allowing for 1-2 days of remote work.\n\n*\nSupport your professional development through internal and external training and certification programs.\n\n*\nAttractive benefits (security, flexibility, support and well-being).\n\n*\nEngaging employee programs.\n\nWHAT YOU´LL BE DOING\n\n*\nLead global regulatory activities to ensure compliance with FDA 21 CFR 820, ISO 13485, and international medical and non-medical device regulations\n\n*\nDefine and implement regulatory strategies across the full product lifecycle, from development to post-market\n\n*\nPartner with Product Management, Logistics, and Engineering teams to ensure compliant product development and global market access\n\n*\nEstablish and optimize global processes for trade compliance, import/export, and supply chain regulatory requirements\n\n*\nGuide and mentor a team of hardware and software development engineers, providing regulatory expertise across projects such as respiratory, imaging, and cardiac safety solutions\n\n*\nAssess regulatory impact of changes to design, materials, labeling, software, and suppliers\n\n*\nSupport regulatory submissions, including FDA 510(k) filings and international product registrations\n\n*\nReview and approve product labeling, technical documentation, and marketing materials to ensure regulatory alignment\n\n*\nParticipate in internal, external, and vendor audits and contribute to corrective and preventive action initiatives\n\n*\nAct as Person Responsible for Regulatory Compliance (PRRC) under MDR requirements\n\n*\nOversee the development and maintenance of SOPs and work instructions aligned with global standards\n\n*\nSupport post-market surveillance, vigilance reporting, and continuous improvement activities\n\nWHAT WE LOOK FOR\n\n*\nMaster’s degree in Engineering, Life Sciences, or a related technical field\n\n*\n6+ years of experience in the medical device industry\n\n*\n4+ years of experience in Regulatory Affairs within medical devices or pharmaceutical products\n\n*\n3+ years of proven leadership experience managing or guiding teams\n\n*\nStrong knowledge of FDA regulations, ISO standards, and global medical device requirements (including 510(k) submissions and MDR)\n\n*\nExperience interacting with regulatory authorities and supporting audits and inspections\n\n*\nUnderstanding of clinical trial environments and GCP is highly desirable\n\n*\nExcellent analytical, organizational, and communication skills\n\n*\nFluency in English and German\n\n*\nDetail-oriented with strong problem-solving capabilities and the ability to manage complex regulatory challenges\n\nAt Clario, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.\nAnsprechpartner\nNathalie Fischer\n\nJetzt bewerben [https://clarioclinical.wd1.myworkdayjobs.com/en-US/clarioclinical_careers/details/Director--Regulatory-Affairs--f-m-d-_R17870]","responsibilities_text":null,"requirements_text":null,"status":"open","duplicate_of":null,"first_seen":"2026-11-02T15:00:25.297150+00:00","responsibilities_summary":null,"requirements_summary":null,"all_tools":["R","Agile","Google Cloud"],"posting_language":"en","evidence":[{"language":"german","requirement":"required","quote":"Fluency in English and German","source":"rules"},{"language":"english","requirement":"required","quote":"Fluency in English and German","source":"rules"}],"years_experience_max":null,"mobility_evidence":[],"model_version":"rules-8","english_badge":"English required","company_id":null}