Junior Regulatory Product Maintenance specialist

Orthofix Holdings, Inc.; Verona; Ibrido; EUR 30.000 - 35.000; Tempo pieno

Vantaggi offerti da questo lavoro

Canteen

Pension Fund & Health Insurance

Training and development opportunities

Descrizione del lavoro

Orthofix Holdings, Inc. in Bussolengo (Verona) seeks a Junior Regulatory Product Maintenance specialist on a 1-year temporary contract.

You will ensure regulatory documentation is up to date, maintain EU Product Technical Files, and support regulatory submissions in a global framework. You will collaborate with Regulatory Technical Product and RA Administrative specialists, interface with Notified Bodies, and help with leaflets, IFU updates, and labeling maintenance.

Competenze

• Bachelor level or higher technical degree in a relevant field.
• Proficient English and Italian, both written and spoken.
• Knowledge of medical device European MDR and related regulatory knowledge is a plus.
• Analytical mindset with ability to interpret regulatory data and trends.
• Experience in project management and coordinating across teams.

Mansioni

• Maintain Regulatory Technical Files in line with MDR and other regional requirements.
• Update EU product Technical Files and FDA product applications in collaboration with departments.
• Prepare and maintain up-to-date procedure packs and labeling materials.
• Support daily regulatory activities and coordinate with Notified Bodies.
• Liaise with internal teams, consultants, distributors, suppliers; travel approx. 10%.

Conoscenze

Technical degree

English and Italian

Regulatory knowledge

Analytical approach

Project management

Formazione

Technical degree

Descrizione del lavoro

## Junior Regulatory Product Maintenance specialistApply: Verona - Bussolengo: Full time: Posted Yesterday: OFX26331**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 Regulatory Product Maintenance specialist** to join our **Regulatory Affairs** team, based in Bussolengo (Verona) on a temporary contract of 1 year. You will report to the **Regulatory Affairs Manager.**You will be collaborate with Regulatory Technical Product and RA Administrative specialists to assure that the Product Technical documentation Files and related documentation are up to date in compliance to the international regulatory requirements in time with 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 Technical documentation on paper or on electronic relevant to a new or modified products is adequately updated and archived in the proper Technical File (DMF) and indexes are up to date.* Maintain UpToDate Regulatory EU Product Technical Files and FDA Product Applications File in collaboration with departments, complete and accurate and available for regulatory Product(s) Applications International submission on time to the planned deadline, as indicated by Regulatory Affairs manager and/or RA team.* 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 Product technical sheet in Italian and English version* Interface with Notified body for the update of the Technical Documentation Files maintenance* Supporting the International registrations documentation’ requests* Supporting for the Products leaflets/IFU and labeling maintenance* Collaborate for any changes to Product impacting the regulatory documents* Travel 10%**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?*** *1 year temporary contract** *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