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 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))
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. Especially Consultants, Subsidiaries, Competent Authorities, Distributors, External laboratories, suppliers colleagues and Third-Party Regulatory agencies (NB, FDA, etc.).
What will your contribution be?
Program, prepare and maintain up-to-date International product/facility(ies) submissions including international registrations and/or license applications, according to approved Budget Sales.
Identifies, plans and collects regulatory submission documents for International markets under minimal supervision, in collaboration with Global Company(ies) departments.
In collaboration with the team verify that all domestic and International Regulatory documents are adequately prepared and collected before the international Product(s) ' Application registrations.
Provide 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.
Contribute to prepare 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.
Collaborates during Internal and Third Party Audits for Device Marketing Authorization and Facility
Registration process.
Manage any change(s) by ECO in Oracle system.
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. T ransferring the identified Product input regulatory requirements to ensure proper and adequate technical documentation for product registration/licensing in respect to planned timeline.
Edit and amend the Technical File structure and verifie 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.
Prepares, 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.
Represents 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.
Manage 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.
Prepare and maintain updated Procedure Pack Files.
Country codes management
What are we looking for?
Technical degree
5+ years in 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. PLM system Oracle system
Good management skills and relationship skills
What soft skills will you improve?
Precision
Accountability
Problem Solving
Communication skills
Multitasking projects and manage priorities accordingly
What will you find?
Friendly, warm, and innovative atmosphere
Healthy, inspiring, and international and inclusive work environment
training and development opportunities
Smart working model (two days per week)
Competitive reward packages
Social and company events
Wellbeing initiatives (welfare)
Canteen
Benefits (Pension Fund- Health Insurance)
What we offer?
This is a full-time job
The contract is permanent contract
Salary package range: 42.000/45.000 euro
Do you want to join us? Are you ready to make the difference? We look forward to your application. Please send it to ******
#J-18808-Ljbffr