PpWe offer an interesting opportunity to join our Regulatory Affairs team, based in Bussolengo (VR) as Senior International Regulatory Specialist, reporting to the Regulatory Affairs Manager. /ppThis position ensures that global product international regulatory submissions activities are completed in a timely manner so that full compliance with all applicable global regulatory requirements and internal product/project goals is maintained. The person is also to assure availability of Technical Documentation File by preparing and maintain up to date the regulatory Product Application Files applicable for any new or modified Products. (e.g. EU-MDR Technical Documentation File, FDA 510(k)) /ppResponsibilities include collaboration with Quality Engineering and RD Departments and other functional areas in the application of all identified regulatory requirements for ensuring Technical Product Documentation File is adequate and accurate for successful regulatory submissions and approvals in each impacted country. /ppThis position must deal with other company departments (mainly Sales) and international colleagues. Especially Consultants, Subsidiaries, Competent Authorities, Distributors, External laboratories, suppliers colleagues and Third-Party Regulatory agencies (NB, FDA, etc.). /ph3What will your contribution be? /h3ulliProgram, prepare and maintain up-to-date International product/facility(ies) submissions including international registrations and/or license applications, according to approved Budget Sales. /liliIdentifies, plans and collects regulatory submission documents for International markets under minimal supervision, in collaboration with Global Company(ies) departments. /liliIn collaboration with the team verify that all domestic and International Regulatory documents are adequately prepared and collected before the international Product(s) ‘ Application registrations. /liliProvide in timely manner the RA Regulatory Intelligence Specialist (RIS) of any regulatory product registration/submission information status to able the RIS Specialist to update the RAMS platform on time. /liliContribute to prepare regulatory strategies for new/modified products in the planned markets. /liliProvide market regulatory affairs support during external inspections (FDA, NBs, Regulatory Agency etc.). /liliPlan and support the Regulatory Administration specialist for the preparation of Free Sales Certificate and any International documents to be legalized. /liliCollaborates during Internal and Third Party Audits for Device Marketing Authorization and Facility Registration process. /liliManage any change(s) by ECO in Oracle system. /liliMember of the NP team and Product Reviews Board, participating, preparing and assuring that the regulatory deliverables are duly prepared during the NP - Reviews processes in due time. Transferring the identified Product input regulatory requirements to ensure proper and adequate technical documentation for product registration/licensing in respect to planned timeline. /liliEdit and amend the Technical File structure and verifie regulatory conformity of Technical documentation in collaboration with Quality Engineering and RD necessary for Products application submission in EU, US and ROW countries, as required. /liliPrepares, reviews and maintain UpToDate Regulatory EU Product Technical Files and FDA Product Applications File in collaboration with departments, complete and accurate, available for regulatory Product(s) Applications submission on time for the planned submission deadline. /liliRepresents Technical Regulatory Affairs on assigned project(s) during the new/modified product Design Development phase and participate in cross-functional meetings with specific focus on product essential principles/requirements to provide regulatory perspective and interpretative knowledge. /liliManage any Deficiency and/or Nonconformity related to a RA Product Technical Files received by Authority or Third Party, in collaboration with other departments, by assuring a proper adequacy and regulatory conformity in the documentation impacted. /liliPrepare and maintain updated Procedure Pack Files. /liliCountry codes management. /li /ulh3What are we looking for? /h3ulliTechnical degree /lili5+ years in similar position preferably in a Medical Device Company /liliExcellent English written and spoken required /liliDeep knowledge of international standards and regulations (in particular US-FDA/CFRs European MDR, etc). /liliProject management. PLM system Oracle system /liliGood management skills and relationship skills /li /ulh3What soft skills do you need? /h3ulliPrecision /liliAccountability /liliProblem Solving /liliCommunication skills /liliMultitasking projects and manage priorities accordingly /li /ulh3What will you find? /h3ulliFriendly, warm, and innovative atmosphere /liliHealthy, inspiring, and international and inclusive work environment /lilitraining and development opportunities /liliSmart working model (two days per week) /liliCompetitive reward packages /liliSocial and company events /liliWellbeing initiatives (welfare) /liliCanteen /liliBenefits (Pension Fund- Health Insurance) /li /ulh3What we offer? /h3ulliFull-time permanent position. /liliSalary package: around 43k/45k (depending on seniority and skills). /li /ul /p #J-18808-Ljbffr