Senior International Regulatory Specialist We 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.
This 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 maintaining 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)).
Responsibilities include collaboration with Quality Engineering and R&D 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.
This position must deal with other company departments (mainly Sales) and international colleagues, including Consultants, Subsidiaries, Competent Authorities, Distributors, External laboratories, suppliers, and Third-Party Regulatory agencies (NB, FDA, etc.).
What will your contribution be? Program, prepare and maintain up-to-date International product/facility submissions including international registrations and/or license applications, according to approved Budget Sales. Identify, plan, and collect regulatory submission documents for International markets under minimal supervision, in collaboration with Global Company departments. Verify that all domestic and International Regulatory documents are adequately prepared and collected before the international Product(s) Application registrations. Provide timely updates to the RA Regulatory Intelligence Specialist (RIS) on regulatory product registration/submission information status. Contribute to preparing regulatory strategies for new/modified products in the planned markets. Provide market regulatory affairs support during external inspections (FDA, NBs, Regulatory Agency, etc.). Plan and support the Regulatory Administration specialist for the preparation of Free Sales Certificate and any International documents to be legalized. Collaborate during Internal and Third Party Audits for Device Marketing Authorization and Facility Registration process. Manage any change(s) by ECO in Oracle system. Be a member 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. Edit and amend the Technical File structure and verify regulatory conformity of Technical documentation in collaboration with Quality Engineering and R&D necessary for Products application submission in EU, US, and ROW countries, as required. Prepare, review, and maintain up-to-date Regulatory EU Product Technical Files and FDA Product Applications File in collaboration with departments, ensuring complete and accurate submissions on time for the planned submission deadline. Represent Technical Regulatory Affairs on assigned project(s) during the new/modified product Design Development phase and participate in cross-functional meetings. Manage any Deficiency and/or Nonconformity related to a RA Product Technical Files received by Authority or Third Party, ensuring proper adequacy and regulatory conformity in the documentation impacted. Prepare and maintain updated Procedure Pack Files. Manage country codes. What are we looking for? Technical degree 5+ years in a similar position, preferably in a Medical Device Company Excellent English written and spoken required Deep knowledge of international standards and regulations (in particular US-FDA/CFRs, European MDR, etc.) Project management experience with PLM system Oracle Good management and relationship skills What soft skills will you improve? Precision Accountability Problem Solving Communication skills Multitasking and managing priorities accordingly What will you find? Friendly, warm, and innovative atmosphere Healthy, inspiring, and inclusive work environment Training and development opportunities Smart working model (two days per week) Competitive reward packages Social and company events Wellbeing initiatives Canteen Benefits (Pension Fund, Health Insurance) What we offer? This is a full-time job The contract is permanent Salary package range: 42,000/45,000 euro Do you want to join us? Are you ready to make a difference? We look forward to your application. Please send it to ******
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