International Regulatory Specialist Ne

International Regulatory Specialist
Ne
Liguria, Ne

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