International Regulatory Specialist

7 giorni fa

Bussolengo, Italia Orthofix A tempo pieno

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?**
- Identifies, plans and collects regulatory submission documents for International markets under mínimal 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

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