Laboratory Quality & Regulatory Manager

Proclinical is advertising a vacancy for a Laboratory Quality & Regulatory Manager position with a leading biotechnology company that focuses on developing and commercialising reliable products for diagnosing severe infectious diseases. Based in Austria, this organisation is seeking for a driven and ambitious applicant to join their team. This is an exciting opportunity to provide expertise to a dynamic and innovative company.

Job Responsibilities:

• Establishing and maintaining the laboratory's quality management system in compliance with ISO 15189 and ED-IVD-R.
• Partnering with the Head of Laboratory in the development and implementation of departmental policies, SOPs, and WIs.
• Planning, coordinating, and directing the quality operations of the clinical laboratory to ensure accurate, quality-driven services are provided to assist clinicians in the diagnosis and treatment of patients with severe infections.
• Planning and implementing regular quality trainings and competence evaluation of new and current laboratory personnel.
• Evolving the company's quality system to comply with EU-IVD-R, ISO 13485, and FDAR 21 CFR part 830 for IVD development; developing and implementing regulatory strategies for the company's IVD products for the EU and US market.

Skills and Requirements:

• Strong knowledge of clinical laboratory and IVD-related regulatory requirements (ISO 15189, ISO 13485, EU-IVD-R, and FDA 21 CFR part 820).
• Demonstrable knowledge of current technical, quality control, quality assurance procedures, and laboratory information systems.
• Thorough knowledge of Quality Management and Performance Improvement principles and tools.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Tanja Ruschenschmidt at + 207 440 0632 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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