Product Regulatory Affairs Specialist- Maternity - Bussolengo, Italia - Orthofix

Descrizione

We offer an interesting opportunity to join our Regulatory Affairs team, based in Bussolengo (VR) a Product Regulatory Affairs Specialist, reporting to the Regulatory Affairs Manager.

The Product RA Specialist is mainly 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))

What will your contribution be?

• She/he is member of the NP team and Product Reviews Board, by participating, prepare and assure that the regulatory deliverables are duly prepared during the NP
• Reviews processes in due time.
• As member of the Technical Review Board works 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, assesses and analyzes any impacted technical documentation with Regulatory Intelligence and RA Global Product International submission specialists for ensuring regulatory requirements for targeted markets are addressed and met prior to commercial release on markets.

• Prepares, reviews 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.
• Represents Technical Regulatory Affairs on assigned project(s) during the new/modified product Design Development phase and participate in crossfunctional meetings with specific focus on product essential principles/requirements to provide regulatory perspective and interpretative knowledge.
• Manage any Deficiency and/or Nonconformity 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.
• Collaborates during Internal and Third Part Audits for Technical Documentation process as a linkage from Regulatory and Design Development processes.

What are we looking for?

• Technical degree
• 3+ years in similar position preferably in a Medical Device Company
• Fluent English, both written and oral
• Deep knowledge of international standards and regulations (in particular US-FDA/CFRs European MDR, etc).

What soft skills will you improve?

• Problem solving.
• Work precisely according to procedures, rules, and regulations.
• Result oriented.
• Skill as autonomy, orderliness, attention to detail and deadline.
• Analytical and attention to regulatory details.
• Responsibility for the assigned tasks.
• Able to work in team and autonomously as well.
• Open mind to different culture.
• Be able to handle multiple tasks and projects and manages priorities accordingly.

What will you find?

• Friendly, warm, and innovative atmosphere
• Healthy, inspiring, and international and inclusive work environment
• Training and development opportunities
• Smart working model (two days per week)
• Competitive reward packages
• Social and company events
• Wellbeing initiatives (welfare

- yoga classes)

• Canteen
• Benefits (Pension Fund
• Health Insurance)

What we offer?

• This is a fulltime job.
• The contract is a maternity substitution.
• Salary package range: 32.000/35.000 euro