Junior International Regulatory Specialist

Orthofix; Bussolengo; On-site; EUR 30,000 - 35,000; Full time

Benefits offered by this job

Pension Fund

Health Insurance

Canteen

Training & development

Wellbeing initiatives

Social events

Job summary

Orthofix is seeking a Junior International Regulatory Specialist to join the Regulatory Affairs team in Bussolengo (Verona) on a maternity substitution contract. You will collaborate with Regulatory International area and RA Administrative specialist to ensure international product registrations are compliant and submitted on time.

The role requires English and Italian proficiency, a technical degree, and the ability to work with multiple internal and external stakeholders across regions.

Qualifications

• Technical degree required.
• Experience in regulatory affairs for medical devices is preferred.
• Strong English and Italian language skills (written and spoken).
• Knowledge of MDR and other major regulations is a plus.
• Ability to coordinate with multiple stakeholders and teams.

Responsibilities

• Ensure regulatory documentation for new or modified products is up to date for international registrations.
• Provide timely status updates on regulatory submissions to update files/databases.
• Prepare and maintain updated Procedure Pack Files.
• Support daily regulatory activities as directed by Regulatory Manager.
• Maintain up-to-date international data bases (e.g., Eudamed, UDI).
• Assist during audits/inspections by Notified Bodies or authorities.

Skills

Regulatory knowledge

English & Italian

Organizational skills

Project management

Team collaboration

Education

Technical degree

Job description

Why Orthofix?

Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.

Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further.

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

You will collaborate with Regulatory International area and RA Administrative specialist to assure International Product/facility(ies) application submissions including international registrations and/or license applications, are up to date in compliance to the international regulatory requirements and in time with requested deadline.

Responsibilities include collaboration with all internal departments, consultants, subsidiaries, distributors, external laboratories and suppliers for successful regulatory activities in each impacted area.

What will your contribution be?

• Assure, that the Regulatory International documentation on paper or on electronic relevant to a new or modified products is adequately updated for International Products applications.


• 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)


• 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


• 1 years in similar position preferably in a Medical Device Company


• Good English and Italian, both written and oral


• 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..)


• Working Hours: 8:30-17:30 Monday to Thursday and 8:30-16:30 Friday.

What do we offer?

• maternity substitution


• Full time


• 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