About the role

Aplyr's Quick Take

This role is for a Junior International Regulatory Specialist focused on ensuring compliance with international medical device regulations. You'll handle documentation, assist with product registrations, and support the regulatory team, reporting to a manager. It's an entry-level position suitable for someone with a technical degree and some experience in regulatory affairs.

Good fit

Ideal candidates are recent graduates or those with about a year of experience in regulatory roles, especially in medical devices. Strong English and Italian skills are necessary, along with a detail-oriented and collaborative working style.

Worth noting

This position is a maternity cover, which may imply a temporary role. The job requires knowledge of various international regulations, which could be a steep learning curve for some.

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

Aplyr's read

Orthofix is a dynamic player in medical devices, attracting professionals passionate about advancing musculoskeletal healing and spine surgery solutions.
Synthesized from recent postings & public sources

What's promising

•Orthofix is committed to innovation in musculoskeletal healing and spine surgery.
•The company offers diverse roles from engineering to sales, indicating growth and varied career paths.
•Orthofix's global presence provides opportunities for international collaboration and exposure.

What to watch

•The medical device industry faces stringent regulatory challenges impacting product timelines.
•Orthofix operates in a competitive market with pressure to continuously innovate.
•Limited public information about company culture and employee satisfaction.

Why Orthofix

•Orthofix specializes in spine and musculoskeletal solutions, setting it apart in the medical device sector.
•The company focuses on both biologics and enabling technologies, offering a broad product range.
•Orthofix's commitment to bone growth therapies highlights its niche expertise.

Aplyr’s read is generated by AI from public sources. Was it useful?