Orthofix

Develops spine and orthopedic reconstructive devices

Junior International Regulatory Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBussolengo, Italy€30k - €35k /yrIn-person

About the Job

Requirements

A technical degree.
One year of experience in a similar position; experience in a medical device company is preferred.
Good written and oral English and Italian.
Knowledge of European Medical Device Regulation (MDR); knowledge of additional regulations, such as U.S., Japanese, Canadian, Latin American, Middle Eastern, Indian, or Asia-Pacific regulations, is a plus.
Technical knowledge of medical devices and the company’s manufacturing processes.
Ability to work precisely according to procedures, rules, and regulations.
Project management skills.
Ability to work both autonomously and as part of a team.
Ability to work under pressure and manage assigned multitasks.

Responsibilities

Collaborate with the Regulatory International area and Regulatory Affairs administrative specialist to keep international product and facility application submissions, registrations, and license applications up to date, compliant with international regulatory requirements, and on schedule.
Collaborate with internal departments, consultants, subsidiaries, distributors, external laboratories, and suppliers to support regulatory activities in each impacted area.
Ensure paper and electronic regulatory documentation for new or modified products is appropriately updated for international product applications.
Provide regulatory product registration and submission status information in a timely manner so the regulatory file platform and data can be updated on time.
Prepare and maintain Procedure Pack Files.
Support the Regulatory team’s daily activities as directed by the Regulatory Manager.
Prepare and maintain international databases, including Eudamed and UDI data.
Support audits and inspections conducted by Notified Bodies or Competent Authorities for facility certification.

Desired Qualifications

Experience in a medical device company.
Knowledge of additional regulations, including U.S., Japanese, Canadian, Latin American, Middle Eastern, Indian, and Asia-Pacific regulations.

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?

Assures, 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

About the Company

Orthofix

Develops spine and orthopedic reconstructive devices

Orthofix Medical Inc. focuses on reconstructive and regenerative orthopedic and spine solutions for surgeons and hospitals. It operates in two groups: Global Spine, which offers spinal fusion products such as bone growth stimulators, spinal implants, and biologics, and Global Orthopedics, which provides devices for fracture fixation, deformity correction, and bone reconstruction. The company’s products are used to treat musculoskeletal conditions like degenerative disc disease, spinal stenosis, and fractures, and are sold through a direct sales force and a network of independent distributors in the U.S. and internationally. Orthofix grows by developing and commercializing new products and by acquiring complementary technologies and businesses, expanding its portfolio and market reach. Its goal is to improve musculoskeletal health by delivering a broad range of surgical solutions for spine and orthopedic care.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Lewisville, TX
Founded: 1980

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