Technical Product RA Specialist

Location: Bussolengo

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 Up To Date  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,…