Clinical Quality Specialist

Kelly Science, Engineering, Technology & Telecom; Brussel; Sur place; EUR 60 000 - 85 000; Plein temps

Résumé du poste

Healthcare Innovators is seeking a Clinical Quality Specialist to supervise and enhance quality across clinical studies for medical device and diagnostic programs. You will partner with international teams to ensure compliance with regulatory requirements and rigorous documentation standards.

The role involves coordinating audits, CAPA processes, and continuous improvement initiatives within a multi-country environment, ensuring alignment with ISO 14155 and global guidelines.

Qualifications

• 4+ years in clinical quality assurance or GCP compliance.
• Strong knowledge of ISO 14155 and 21 CFR parts applicable to clinical studies.
• Excellent written communication and independent decision-making.

Responsabilités

• Evaluate study documentation for regulatory and company standards.
• Coordinate process improvements and CAPA activities.
• Organize internal and external audits and address audit findings.
• Assist in audits for regulatory inspections and liaise with cross-functional teams.
• Lead investigations for CAPA and ensure closure.

Connaissances

Regulatory knowledge

GCP compliance

Audit management

Documentation control

Formation

Graduate degree in life sciences or related field

Description du poste

Clinical Quality Specialist (Medical Devices)

Full-Time | 40 Hours/Week | 12-Month Fixed-Term Contract

About the Business

This opportunity is with a prominent global healthcare company recognised for developing advanced medical devices and diagnostic solutions serving millions worldwide. With a strong commitment to innovation and clinical excellence, the business drives improvements in patient care through cutting-edge medical technology. Operating across many countries, their medical device offerings span cardiac therapies, surgical tools, and other solutions that support the evolving needs of healthcare professionals and patients. Upholding rigorous quality and regulatory standards is central to their mission.

Position Overview

The Clinical Quality Specialist works closely with international clinical teams to ensure all research and trials are conducted to the highest quality standards. This role involves overseeing document compliance, coordinating process enhancements, and facilitating both internal and external audits. The associate will champion quality assurance efforts throughout clinical studies and provide expert guidance to teams on regulatory matters.

Primary Responsibilities

• Evaluate study documentation to confirm conformity with regulatory and company standards.
• Offer expert support to clinical research teams regarding compliance and process requirements.
• Assist in the smooth and compliant launch of clinical projects, collaborating with colleagues across departments.
• Lead investigations and resolutions for process deviations through the CAPA system, overseeing corrective and preventive actions to completion.
• Continually seek ways to elevate internal processes, ensuring alignment with industry best practices and regulatory guidelines.
• Organise and support both internal and external audit activities, including addressing audit issues through documented solutions.
• Conduct compliance reviews and internal audits to ensure preparedness for regulatory inspections.
• Advise and assist project groups preparing for external reviews from regulatory bodies.
• Undertake other duties related to clinical quality as needed.

Requirements

• Graduate degree or similar qualification in a relevant discipline, with equivalent experience considered.
• At least 4 years in a role focused on clinical quality assurance or GCP compliance.
• In-depth knowledge of industry regulations and international standards relating to clinical research (including ISO 14155 and relevant parts of 21 CFR).
• Strong skills in written communication and proven capacity for independent, informed decision-making.
• Resourceful in problem solving, planning, and capable of working autonomously.

Preferred Experience

• Minimum of 5 years in the medical devices sector, clinical research, or similar field.
• At least 3 years managing quality processes in a regulated clinical or medical device environment.
• Prior active involvement in GCP audits is especially valued.
• Position contingent upon final approval of project commencement; currently part of a pending project pipeline.
• Medical devices experience is essential due to the specialised nature of the role.
• 12-month contract, full-time commitment.