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 Technical Product RA Specialist to join our Regulatory Affairs team, based in Bussolengo (Verona) as a maternity substituition. You will report to the Regulatory Affairs Manager.
You will be responsible to assure availability of Technical Documentation File by preparing and maintain up to date the regulatory Product Application Files applicable for any new or modified Products. (e.g. EU-MDR Technical Documentation File, FDA 510(k))
Responsibilities include collaboration with Quality Engineering and R&D Departments and other functional areas in the application of all identified regulatory requirements for ensuring Technical Product Documentation File is adequate and accurate for successful regulatory submissions and approvals in each impacted country.
What will your contribution be?
You will be a member of the NPI team and Product Reviews Board, by participating, prepare and assure that the regulatory deliverables are duly prepared during the NPI - Reviews processes in due time.
You will edit and amends the Technical File structure and verifies regulatory conformity of Technical documentation in collaboration with Quality Engineering and R&D necessary for Products application submission in EU, US and ROW countries, as required.
As member of the Technical Review Board you will work closely with any specific department for new/modification products and design changes by transferring the identified Product input regulatory requirements to ensure proper and adequate technical documentation for product registration/licensing in respect to planned timeline.
For any new- modification products and/or design changes, assess and analyz any impacted Technical documentation with Regulatory Intelligence and RA Global Product International submission ensuring regulatory requirements for targeted markets are addressed and met prior to commercial release on markets.
Prepare, review and maintain UpToDate Regulatory EU Product Technical Files and FDA Product Applications File in collaboration with departments, complete and accurate, available for regulatory Product(s) Applications submission on time for the planned submission deadline.
Represent Technical Regulatory Affairs on assigned project(s) during the new/modified product Design Development phase and participate in cross-functional meetings with specific focus on product essential principles/requirements to provide regulatory perspective and interpretative knowledge
Manage any Deficiency and/or Non conformity related to a RA Product Technical Files received by Authority or Third Party, in collaboration with other departments, by assuring a proper adequacy and regulatory conformity in the documentation impacted.
Prepare and maintain updated Procedure Pack Files
Manages country code management at Oracle system
Manage any changes by ECO in Oracle system
Travel 10%
What business skills are we looking for?
Technical degree
3+ years in similar position preferably in a Medical Device Company
Good English, both written and oral
Deep knowledge of international standards and regulations (in particular US-FDA/CFRs European MDR, etc).
Technical knowledge of the Company’ Products and of the manufacturing processes.
Project management. PLM system Oracle system
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 Substition
Salary range: 40.000/43.000 Euro annual*
*please note that this is a range; the complete salary package will be defined based on the seniority / skills of the person
DISCLAIMER
The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee’s at-will employment status.
We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.
This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.
Skills Required
- Technical degree
- 3+ years in a similar Regulatory Affairs position
- Experience in a Medical Device company
- Good English, written and oral
- Deep knowledge of international standards and regulations (EU MDR, US FDA/CFRs)
- Technical knowledge of products and manufacturing processes
- Project management skills
- Experience with PLM systems and Oracle
- Experience preparing and maintaining Technical Documentation Files and FDA 510(k) applications
- Willingness to travel up to 10%
Orthofix Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Orthofix and has not been reviewed or approved by Orthofix.
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Healthcare Strength — The company highlights comprehensive medical plan options supported by wellness resources and an Employee Assistance Program, alongside company-paid life and disability coverage. Feedback suggests the health offering is competitive for a mid-sized med‑tech firm.
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Retirement Support — A 401(k) with company match is part of the core package, with public filings indicating a solid employer contribution structure. Feedback suggests the retirement program is a notable pillar of total rewards.
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Equity Value & Accessibility — An Employee Stock Purchase Plan is available and frequently called out as a meaningful benefit. Feedback suggests this ownership feature is a differentiator among some peers.
Orthofix Insights
What We Do
Orthofix Medical Inc. began in a small farmhouse in Verona Italy in 1980 when orthopedic researcher Giovanni De Bastiani recognized the bone’s natural repair capability, a concept he called “dynamization.” With that in mind, he created the first external fixation device. Today, Orthofix has grown to more than 1,200 employees with locations in the U.S., Italy, Germany, France, the U.K., Brazil, and Australia. Our products help patients in more than 70 countries around the world. The Company’s mission is to deliver innovative, quality-driven solutions as we partner with health care professionals to improve patient mobility. Headquartered in Lewisville, Texas, the company has two strategic business units: Spine and Orthopedics. Orthofix products are widely distributed via the company's sales representatives and distributors. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as MTF Biologics, the Orthopedic Research and Education Foundation, and the Texas Scottish Rite Hospital for Children. Orthofix makes a difference in the lives of others by providing our surgeon customers with innovative medical devices to meet the needs of their patients. Every day we are optimizing our operations, improving efficiencies, and examining our systems to provide the best support possible to our representatives, surgeons and patients.
