Quality Assurance and Regulatory Affairs Manager – Market Access (Sector: Medical devices)

Job Overview

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. As a growing company, we are now recruiting a Quality Assurance (QA) and Regulatory Affairs (RA) Manager.

The QA/RA Manager serves as a strategic pillar at Recornea, ensuring that our innovative ophthalmic solutions meet the highest global standards for safety and efficacy. This role bridges the gap between clinical innovation and global market availability.

Responsibilities

QMS Oversight & Maintenance

• Develops, maintains, and continuously improves the QMS in compliance with ISO 13485:2016, ISO 14971, EU MDR, FDA 21 CFR Part 820 and other regulations ensuring it scales with the company’s growth.
• Develops, implements and customizes templates, SOPs, policies, etc. in accordance with ISO 13485:2016.
• Ensures compliant updated documentation and records management systems, ensuring documentation is always "audit-ready".
• Leads cross-functional quality planning in collaboration with R&D, Clinical to ensure compliance throughout the product lifecycle, from design freeze to market.
• Develops and manages the company training plan, ensuring all staff are proficient in quality procedures and updated on applicable evolving industry regulations.
• Establishes and tracks quality metrics and KPIs, reporting QMS performance directly to the CEO and drives initiatives to improve product/process quality and optimization.

Risk Management, Audit & Compliance

• Leads and conducts risk evaluation, assessment and management (ISO 14971) and usability processes (IEC 62366-1) for Recornea’s products, guiding activities, documentation, and cross-functional input throughout all stages of the product development lifecycle, including maintaining the risk management plan, risk file, and usability strategies.
• Plans and executes internal and external audits, including third parties (suppliers, vendors, etc.) qualifications and acting as the primary lead during Notified Body or FDA/Competent Authorities inspections.
• Ensures CAPA and non-conformance investigations are conducted and resolved in a timely manner, effectively analyzing the root-cause.
• Monitors whether processes, products, and services are controlled and meet QMS guidelines, intervening and adjusting, where necessary, and reporting on the performance of the QMS to the CEO to improve company efficiency and maintain high standards.

Regulatory

• Defines, drives and manages the regulatory activities, building proper global regulatory strategies (e.g. EU, USA, Asia) to support the clinical planning and business implementation to ensure the most efficient market access strategy.
• Manages the regulatory tasks in launching multiple new product development projects as part of a multifunctional team, in accordance with the company’s 5- year commercial plan.
• Supports the Clinical Trial Manager in preparing clinical trial applications (EU CTR, ISO 14155) by providing regulatory checklists and ensuring full compliance with requirements. The role provides regulatory guidance for interactions with Ethics Committees and Competent Authorities, ensures adherence to biocompatibility standards and Good Clinical Practice (GCP), monitors regulatory changes, and approves labeling and promotional materials to ensure successful market access.
• Lead the preparation, submission, and maintenance of the technical documentation for regulatory purposes and regulatory filings for company’s products certification in different geographies (CE Mark, 510(k)/PMA, etc.).
• Acts as the official correspondent and primary contact for EU Notified Bodies, the FDA, and other international regulatory authorities (CDSCO and CNMPA).
• Performs market assessments and monitor global regulatory changes to aid regulatory pathways and worldwide market introduction as part of building the market access strategy.
• Acts as the Person Responsible for Regulatory Compliance (PRRC), ensuring all legal obligations are met and reported to top management.

Education/Qualifications

·      PhD/University degree in Life Science, preferably Biomedical Engineering, Biotechnologies, or Medicine.

·      Proven expertise in QA/RA within the medical device industry, specifically focusing on ISO 13485:2016, EU MDR (2017/745), and FDA 21 CFR Part 820, preferably ocular and/or corneal implants.

·      A good understanding of ophthalmic or implantable medical device environments is highly desirable.

·      Knowledge of corneal disease treatments, including implants, nitinol-based devices, and clinical trials involving corneal or ocular implants, is a significant plus.

·      Certification or advanced training in Good Clinical Practice (GCP) or additional certifications (e.g. ISO 14155) are a plus.

·      Comprehensive understanding of global regulatory activities, including market access strategies for the EU, USA, and Asia (CDSCO, CNMPA) is a plus.

Experience

·      At least 5+ years of experience in QA/RA roles in the EU medical device industry, in particular in ocular and/or corneal implants, with a professional expertise of international quality and regulatory standards for medical devices, e.g. ISO 13485, FDA 21 CFR Part 820 and EU MDR (2017/745), and interactions with regulatory authorities.

·      Ability to independently develop, implement and maintain successfully an efficient QMS compliant with ISO13485 as well as regulatory and certification strategies for medical device, following EU and FDA regulations.

·      Extensive experience in writing and submitting medical device Technical Documentation to EU Notified Bodies, FDA and global regulatory authorities.

·      Experience with the preparation, execution and handling of internal and external audits, including inspections from regulatory agencies or Notified Bodies.

·      Proven track record of successfully acquiring CE marking and FDA certification for medical devices, preferably for ocular and/or corneal implants.

·      Skilled in risk management (ISO 14971), usability processes, and the effective management of non-conformances and CAPAs.

·      Practical experience handling regulatory aspects of clinical investigations, supporting clinical trial applications (EU CTR), and ensuring GCP compliance.

·      Experience acting as the Person Responsible for Regulatory Compliance (PRRC).

·      Ability to interpret legislation and evaluate its impact on the business, translating complex requirements into actionable company procedures.

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

·      Experience with the regulatory pathway of new orphan drugs for EMA is a plus.

·      Excellent planning, time management and organization skills, with ability to prioritize effectively and meet critical deadlines.

·      Proactive “Can do” attitude, with strong accountability, ownership and a commitment to achieving company goals.

·      Comfortable working in a fast-paced environment and effectively switching between competing priorities while maintaining high performance under pressure.

·      Skilled in troubleshooting and autonomous issue resolution.

·      Experience in managing project budgets with documented cost containment strategies, while maintaining compliance.

·      Appreciation of the commercial goals of the organisation and the desire to contribute to the successful fulfilment of these goals.

·      Excellent communication, facilitation and presentation skills, communicating clearly and logically, both orally and in written form.

·      Excellent conceptualization and visual presentation skills.

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

·      Strong analytical interpretation, and visualization skills across projects, with a diligent and accurate approach.

·      Strong interpretation and analytical skills within and across projects / portfolios leading to documented efficiency improvements.

·      Fluent English.

·      Excellent computer skills, including Microsoft Office.

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

·      Valid driving license (B) and availability to travel internationally (20-25% working time).

What do we offer?

·     The chance to make a real impact in the field of ophthalmic medical devices, contributing to solutions that directly improve patients' sight and quality of life.

·     Dynamic position in a young, innovative, clinical stage MedTech company in ophthalmology which is fast growing and evolving every day.

·     Flexible working environment, with hybrid work-from-home options to facilitate and cultivate your personal/family needs.

·     Competitive salary with opportunities to get access to stock incentive packages.

·     Working with a team highly experienced in development of ocular and/or corneal implants.

·     International projects and professional growth.