Junior International Regulatory Specialist

1 settimana fa

Bussolengo, Italia Orthofix A tempo pieno

We are looking for a** Junior International Regulatory**Specialist**,** to join our **Regulatory Affairs** team, based in Bussolengo (Verona). You will report to the Regulatory Affairs Manager.

Excellent time management and interpersonal relationship skills are necessary in this role.

You will interact with all departments, in particular Consultants, Subsidiaries, Distributors, External laboratories and suppliers.

**What will your contribution be?**
- Provide in timely manner any regulatory product registration/submission information status to able to update the Regulatory file platform /data on time
- Prepare and maintain updated Procedure Pack Files.
- As needed, support the Regulatory team in the daily regulatory activities, as indicated by the Regulatory manager
- Prepare and maintain UpToDate International data bases (e.g. Eudamed, UDI, etc)
- Manage country code at Oracle system
- Support during the audit/inspection carried out by Notified Body or Competent Authorities for the facility’s certification

**What business skills are we looking for?**
- Technical degree
- Preferable 1-2 years in similar position preferably in a Medical Device Company
- Good English, both written and oral
- Basic Knowledge of medical device European MDR. Any additional regulations knowledge, such as U.S. Japanese, Canadian, Latin America, Middle East, India,, Asia-Pacific regulations, would be a plus.
- Technical knowledge of the medical devices and of the Company manufacturing processes

**What soft skills are we looking for?**
- Excellent organizational skills and multitasking
- Problem solving
- Work precisely according to procedures, rules and regulations
- Result oriented
- Skill as autonomy, orderliness, attention to detail and deadline
- Analytical approach to regulatory issues
- Project management
- Responsibility for the assigned tasks
- Able to work in team and autonomously as well
- Open mind to different culture
- Able to work under pressure
- Able to work on assigned multitasks

**What will you find?**
- Friendly, warm, and innovative atmosphere
- Healthy, inspiring, and international and inclusive work environment
- Training and development opportunities
- Competitive reward packages
- Social and company events
- Wellbeing initiatives (welfare)
- Canteen
- Benefits (Pension Fund
- Health Insurance etc..)

**What do we offer?**
- Permanent contract
- Salary range: 30.000/35.000 Euro annual*
- please note that this is a range; the complete salary package will be defined based on the seniority / skills of the person

—
- Do you want to join us? Are you ready to make a difference?_

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