Regulatory Affairs Specialist

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Regulatory Affairs Specialist Please see below the JD and Qualifications expected: In this function the position is responsible for all RA deliverables linked to the management with focus on orthopedic systems.The RA Manager will be responsible for developing and executing regulatory strategies for assigned projects while focusing on the main markets, i.e. EU, US and CAN.This will include the creation, review and/or approval of documents of the design control process, development of the technical file and summary of technical documentation.He/she will be responsible for monitoring submission timelines and timely responses to requests by notified bodies or competent authorities. It also includes constant development/ improvement of product development and RA processes.The RA specialist/manager will support international product registration by consulting the responsible RA manager for international projects.Assessing, approval and release of communication material (IFU, leaflets, brochures). Assist other departments to ensure continued compliance and timely market release.Support of product development in cross functional teamsCreation, review and/or approval of documents of the design control processAccountable for regulatory complianceSupport international product registrationAssessment, approval and regulatory implementation of change requestsReview and approval of product related labeling and marketing materialSupport SAP based reporting systemsTraining internally on relevant procedures and requirements QualificationsUnderstanding of regulatory requirements, applicability and implementation in practiceUnderstanding for product development process and principles of design controlUnderstanding for quality system requirementsDevelopment, review and release of all documents required for technical filesInterpersonal skills and multitaskingWork in SAP and office and Google based programsTechnical or scientific background, university degree is an advantageGood Knowledge of medical device legislation EU ,US and CAN and corresponding guidelinesGood knowledge of product development processes in MD industryGood knowledge of quality system requirements such as ISO 13485 and FDA's 21 CFR Part 820Fluent in English, further languages are an advantageHighly organized and able to work under strict time linesStrong interpersonal skills and proactive working attitude in an international matrix organizationExcellent writing and communication skillsExperience in preparation for notified body audits and FDA inspections are an advantageExperience in managing cross functional projects and teams (RA manager position)Minimum 2 to 5 years experience in regulatory affairs within the Medical Device Industry (depending on the role)Experience with EU, US and CAN medical Device regulationsSthree Switzerland is acting as an Employment Business in relation to this vacancy.