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UID:6a07b11081f42@www.leap-up.com
DTSTAMP:20260516T014936Z
DTSTART:20260414T083000
DTEND:20260619T130000
SUMMARY:Specialist for Technical Research\, Development & Regulatory Documentation in Medical Technology - training eligible for funding
DESCRIPTION:In just 10 weeks (part-time)\, you will learn how to provide technical\, regulatory and documentary support for medical device development processes - from the idea to the market launch - as an employee under the Qualification Opportunities Act (QCG) or as a jobseeker with an education voucher.\nYou understand how technical innovations are implemented\, validated and documented for approvals in accordance with standards.\nIdeal for an industry change from automotive to medical technology.\nTarget group\nThis training is aimed at:- Specialists from research\, development or project management in medical technology and the life sciences industry- Job seekers with technical or scientific professional experience- Career changers with an interest in regulatory-technical documentation\nContents of the further training\nModule 1 - Development\, Documentation &amp\; QM Basics (Days 1-6)Day 1 - Technical Development &amp\; Regulatory IntegrationDay 2 - Technical Documentation in the Development ProcessDay 3 - Conformity Assessment and QM IntroductionDay 4 - QM Documentation and Life Cycle ManagementDay 5 - QM IntegrationDay 6 - Risk Management and Design Control\n \nModule 2 - Global Market Access\, Labelling &amp\; Technical Product File (days 7-12)Day 7 - Labelling and DigitisationDay 8 - International Requirements (USA)Day 9 - International Requirements (MSDAP &amp\; Asia)Day 10 - International Requirements (LATAM)Day 11 - Practical Workshop Development File &amp\; Technical Documentation\nModule 3 - Clinical Evidence\, Studies &amp\; Post-Market Activities (Days 13-18)Day 12 - Verification\, Validation &amp\; Fundamentals of Clinical EvaluationDay 13 - Clinical Evaluation (CEP &amp\; CER)Day 14 - Study Design and GCPDay 15 - Clinical Data &amp\; PMCF IDay 16 - PMCF IIDay 17 - Clinical Validation Practice Workshop IDay 18 - Clinical Validation Practice Workshop II\nModule 4 - Technical &amp\; Regulatory Writing &amp\; Completion (Days 19-20)Day 19 - Technical &amp\; Regulatory Writing WorkshopDay 20 - Writing Workshop II &amp\; Completion\nPrerequisites for participation- Completed studies or professional experience in the technical\, scientific or medical field- Good knowledge of English &amp\; basic PC skills- Participation after aptitude assessment in the counselling interview- Career prospects- After completion you will be qualified for activities in:\nResearch &amp\; development of medical devicesRegulatory affairs / technical documentationQuality &amp\; process managementClinical evaluation &amp\; validation documentation\nCostsThe training is AZAV-certified and can be funded up to 100% by the Federal Employment Agency or the job centre (e.g. via an education voucher).For employees\, funding is possible in accordance with the Qualification Opportunities Act (§82 SGB III).If approved\, you will not incur any costs.
LOCATION:Remote
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