Junior Quality Assurance and Regulatory Affairs Associate (Sector: Medical devices)

About us

Recornea Srl is a medical technology company developing minimally invasive therapeutic solutions for treating diseases of the eye. Our core technology focuses on implantable medical devices in nitinol. In particular, we developed an innovative corneal implant for keratoconus, which is under clinical investigation in a first in human clinical trial. As part of our pipeline, we are expanding the application of our core technology to other fields in ophthalmology, such as glaucoma. We are ISO13485-certified company for the design, development, manufacturing and distribution of therapeutic solutions for treating eye diseases in ophthalmology.

Job Overview

As a growing company, we are recruiting a Junior Quality Assurance and Regulatory Affairs Associate (Junior QA/RA Associate) to support Quality and Regulatory activities, with a strong growth path toward increasing independent ownership of QMS and regulatory processes.

Working within the existing QA/RA team and under the supervision of senior personnel, the Junior QA/RA Associate will support day-to-day operational and documentary activities across both quality and regulatory areas.

In particular:

-      Quality: she/he supports the maintenance of the QMS in alignment with ISO 13485 and EU MDR, contributing to documentation activities, change control and records management. She/he assists in the drafting and updating of templates, Standard Operating Procedures (SOPs) and other QMS documentation, in collaboration with internal departments (R&D, Clinical, etc.).

-      Regulatory: she/he supports the preparation and organization of regulatory documentation and submission packages, in accordance with the defined regulatory strategy. She/he may assist in preparing materials for communication with notified bodies and regulatory stakeholders, under supervision.

The role does not include appointment as Person Responsible for Regulatory Compliance (PRRC), nor independent interactions to regulatory authorities.

Responsibilities

Quality

• Supports the maintenance of the QMS in alignment with ISO 13485 and EU MDR.
• Develops, implements and customizes SOPs, templates and quality documentation.
• Manages document control and records.
• Supports quality planning in collaboration with the other departments of the company (R&D, Clinical, etc.).
• Provides quality-related training to internal and external team members, supports the management of the company training plan and ensure continuous updates on applicable industry regulations.
• Tracks quality metrics, assists in establishing KPIs, and drives initiatives to improve product and process quality.
• Manages risk management activities in accordance with ISO 14971 by collecting inputs and maintaining risk documentation under supervision, in collaboration with internal departments and the Risk Management Team.
• Assists in organizing usability documentation throughout the product development lifecycle.
• Supports internal and external audits preparation and follow-up. Participates in audits under the guidance of a lead auditor.
• Supports the management of CAPA, deviations and non-conformities.

·      Supports in supplier qualification and quality assessments.

Regulatory

• Supports preparation of regulatory documentation and submission packages.
• Contributes to cross-functional coordination on assigned tasks.
• Maintains regulatory trackers and documentation.
• Contributes to the development and maintenance of product technical documentation.
• Assists in communication preparation with notified bodies.
• Ensure adherence to defined timelines.
• Supports regulatory intelligence activities and keeps track on the latest.

Education/Qualifications

·      University degree in Life Science, preferably Biomedical Engineering, Biotechnologies, medicine or similar. A PhD is a plus.

·      Academic background or initial professional exposure to Quality Assurance and/or Regulatory Affairs for medical devices is appreciated.

·      A good understanding of ophthalmology, implantable medical devices, nitinol-based devices or related field is a plus.

·      Knowledge of clinical investigations involving ocular implants is a plus.

·      Certification or training in ISO 13485, ISO 14971, Good Clinical Practice (GCP), ISO 14155 or other relevant standards is a plus.

Experience

·      0-2 years of experience in Quality Assurance, Regulatory Affairs, clinical/regulatory documentation or other regulated environments; prior thesis or internship in the medical device sector is valued.

·      Basic knowledge of medical device quality and regulatory standards, including ISO 13485 and EU MDR; familiarity with FDA requirements is a plus.

·      Ability to work accurately within an existing QMS and to support regulated documentation activities.

·      Exposure to audits, CAPA, deviations or document control activities is a plus.

·      Basic knowledge of the ISO 14971 Risk Management Standard is a plus.

·      Ability to interpret regulations and evaluate impact on the business with the support of senior personnel.

·      Proven track record in regulatory submission of medical device technical documentation or interaction with regulatory authorities (e.g. European Notifying Bodies, FDA and EMA) is a plus.

·      Proven track record of successfully acquiring CE marking and FDA certification for medical devices, preferably in ocular implants, is a plus.

·      Experience as Person Responsible for Regulatory Compliance (PRRC) is a plus.

·      Competent in managing new MAA’s European Procedures (MRP/DCP’s) is a plus.

Skills

·      Strong attention to detail and accuracy.

·      Analytical, diligent and structured mindset.

·      Good planning, time management, organizational skills, and ability to prioritize.

·      Problem-solving attitude and ability to escalate appropriately.

·      Ability to manage assigned priorities in a dynamic environment.

·      Good communication skills, both oral and written.

·      Excellent conceptualization and visual presentation skills.

·      Proven ability to operate within cross-functional teams and deliver measurable results with limited supervision.

·      Proactive attitude, reliability and willingness to learn.

·      Good interpersonal skills.

·      Experience in managing project budgets with documented cost containment strategies is a plus.

·      Excellent computer skills, including Microsoft Office.

·      Fluent English.

Other Requirements

·      Based in Trieste (preferably) or willing to relocate in Trieste.

·      Driving license (B) and availability to travel internationally (occasionally, when required).

What do we offer?

·      Dynamic position in a clinical-stage medtech company in ophthalmology which is growing and changing every day.

·      Hands-on experience in Quality Assurance and Regulatory Affairs.

·      Opportunity to progressively take ownership of QMS and regulatory processes.

·      Collaborative, cross-functional and international environment.

·      Professional growth and development opportunities.

·      Exposure to innovative medical devices in ophthalmology, working with a team highly experienced in development of ocular implants.

·      Expected salary range (RAL): € .