Junior International Regulatory Specialist

Orthofix Holdings, Inc.; Verona, Bussolengo; On-site; EUR 30,000 - 35,000; Full time

Benefits offered by this job

Training opportunities

Competitive rewards

Canteen benefits

Wellbeing programs

International work environment

Job summary

Orthofix Holdings, Inc. in Verona, Italy, is seeking a Junior International Regulatory Specialist on a maternity substitution contract. The role reports to the Regulatory Affairs Manager and collaborates with international RA teams to ensure compliant product registrations and licenses.

Requirements include a technical degree and 1 year in a similar role, with fluency in English and Italian. Knowledge of MDR and broader regulatory frameworks is essential; strong organizational and analytical

Qualifications

• Technical degree required; 1 year in a similar role, preferably in a Medical Device company.
• Proficient in English and Italian (written and spoken).
• Knowledge of European MDR.
• Knowledge of other regulations (U.S., Japan, Canada, Latin America, Middle East, India, Asia-Pacific) is a plus.

Responsibilities

• Ensure regulatory documentation for International product registrations is updated.
• Provide timely regulatory submission information to update files and data systems.
• Prepare and maintain up-to-date Procedure Pack Files.
• Support the Regulatory team in daily regulatory activities as directed.
• Maintain UpToDate International databases (e.g., Eudamed, UDI).
• Assist during audits/inspections by Notified Bodies or Competent Authorities.

Skills

English

Italian

Organizational skills

Analytical thinking

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?

• 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

Since 1980, Orthofix has evolved and grown to become one of the leading medical device companies with a spine and orthopedics focus in the world. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide. Our medical device company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, CA, and Verona, Italy. Our combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil. Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the 8th Largest Orthopedic Medical Device Company in the World by Medical Design & Outsourcing magazine. Orthofix is committed to improving patients’ lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet the needs of their patients every day.