We offer an interesting opportunity to join our Regulatory Affairs team, based in Bussolengo (VR) as 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.

This position must deal with other company departments and international colleagues. Especially Consultants, Subsidiaries, Competent Authorities, Distributors, External laboratories and suppliers colleagues.

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 Global RA –Global Regulatory Intelligence and Regulatory Technical Product members 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

What are we looking for?

• Technical degree
• 3+ years in similar position preferably in a Medical Device Company
• Excellent English written and spoken required.
• Good management skills and relationship skills

What soft skills will you improve?

• Precision
• Accountability
• Problem Solving
• Communication skills

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 a fixed term contract of 12 months
• Salary package range: 35.000/40.000 euro

Do you want to join us? Are you ready to make the difference? We look forward to your application. Please send it to careers@orthofix.com