Technical Product RA Specialist

Orthofix Holdings, Inc.; Bussolengo, Verona; On-site; EUR 40,000 - 43,000; Full time

Benefits offered by this job

Canteen Benefits

Pension Fund

Health Insurance

Training and development opportunities

Job summary

Orthofix Holdings, Inc. in Bussolengo (Verona) is seeking a Technical Product Regulatory Affairs Specialist to join our Regulatory Affairs team as a maternity substitution.

You will ensure availability of Technical Documentation File by maintaining EU MDR and FDA submission-ready files and coordinating with Quality Engineering and R&D. The role requires a technical degree and 3+ years in medical devices, strong English, and in-depth knowledge of US FDA CFRs and European MDR.

Qualifications

• 3+ years experience in regulatory affairs for medical devices.
• Strong knowledge of US FDA CFRs and EU MDR requirements.
• Experience with Technical Documentation File (EU MDR) and FDA submissions.

Responsibilities

• Prepare and maintain EU Product Technical Files and FDA Product Applications Files.
• Collaborate with Quality Engineering and R&D to ensure regulatory conformity.
• Participate in NPI reviews and ensure regulatory deliverables are delivered on time.
• Manage regulatory changes and EC in Oracle system.

Skills

Technical degree

Regulatory affairs knowledge

3+ years experience

English proficiency

FDA/EU MDR knowledge

Product knowledge

PLM system

Tools

Oracle PLM

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 Technical Product RA Specialist to join our Regulatory Affairs team, based in Bussolengo (Verona) as a maternity substitution. 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.

Since 1980, Orthofix has evolved 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.