Quality Assurance & Regulatory Affairs Specialist

Research and selection in the field of Regulatory Affairs for a leading group in Medical Devices.

Affari Regolatori Dispositivi Medici: un medico osserva una riproduzione di una protesi

Introduction

A leading group in the orthopedic devices sector commissioned Professional Recruitment to select a Quality Assurance & Regulatory Affairs Specialist for its production site in Northern Milan, the largest and most complex in the entire group.

The goal was to quickly identify a technical profile with solid knowledge of relevant regulations in medical device regulatory affairs, capable of integrating smoothly into a structured team operating in a highly complex production environment.

Requirement

Following the strengthening of the Quality and Regulatory Affairs function, the company identified the need to hire a professional with:

  • Specific experience in regulatory affairs for medical devices, preferably Class IIb and III;
  • Relevant academic background, such as biomedical engineering, pharmacy, or biology;
  • Proven expertise in managing certifications such as ISO 13485, ISO 9001, and MDR.

Affari Regolatori Dispositivi Medici: dei fogli medici con sopra una penna e uno stetoscopio

In addition to technical expertise, the sought-after profile needed to demonstrate flexibility and adaptability. The role involved close interaction with production and all other departments, requiring a consistent on-site presence with limited opportunities for remote work.

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Proposed solution

To meet this need quickly and effectively, a team of headhunters specialized in the medical devices sector was engaged.

The approach was structured on multiple levels:

  • Vertical market mapping, focusing on competitors and organizations with structured regulatory affairs teams in medical devices;
  • Active and customized search, targeting profiles with specific experience in industry regulations;
  • Integrated evaluation, conducted in close collaboration with the Function Manager to assess both technical skills and cultural fit.

The main challenge was identifying candidates with the right mix of regulatory knowledge, motivation, willingness to work full-time on-site, and the ability to adapt to a structured corporate culture.

Results achieved

Thanks to a targeted strategy and constant collaboration with HR and the Function Manager—which included salary benchmarking and market analysis—the process was successfully completed in a short time.

The selected candidate, with a background in regulatory affairs consulting for medical devices, demonstrated strong motivation for the role, hands-on operational experience, and excellent interpersonal skills. Her rapid integration into the team and immediate effectiveness at the production plant confirmed the success of the headhunting process.

Conclusions and future prospects

This project confirms the effectiveness of a specialized and structured approach to recruiting technical and managerial profiles in the medical devices sector.

The onboarding of the new QA & RA Specialist represented a valuable solution, not only addressing the immediate need but also strategically strengthening the quality and regulatory affairs function during a period of significant regulatory and organizational transformation.

Thanks to the deep industry knowledge, the sector-focused expertise of our consultants, and a rigorous methodology, Professional Recruitment continues to stand out as a trusted partner for the search and selection of roles related to regulatory affairs in medical devices.

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