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Head of Quality and Regulatory

Job Description

Head of Quality & Regulatory Affairs in the field of in vitro Diagnostics/SaaS (m/f/d)

My client is seeking an experienced Head of Quality & Regulatory Affairs (m/f/d) with expertise in the field of in vitro diagnostics or SaaS. The ideal candidate will support us in establishing our products in the market and advancing the healthcare market in general.

Your Responsibilities:

·       Development and implementation of quality and regulatory strategies:

·       Ensure compliance with all applicable regulations.

·       Enable innovative, digital, AI-based approaches with creative solutions.

·       Steering the development and maintenance of our Quality Management System (QMS).

·       Involvement in the review, testing, and approval of risk management and product development.

·       Review and approval of product design, specifications, and documentation.

·       Management and submission of approval applications to notified bodies and regulatory authorities.

·       Conducting internal and external audits to ensure compliance with quality and regulatory requirements.

·       Investigating and resolving quality and regulatory issues.

·       Monitoring all applicable normative and legal requirements.

·       Representing the company in regulatory matters at conferences, working groups, etc.

 What We Expect from You:


·       Minimum of 3 years of experience in quality and regulatory affairs in the field of in vitro diagnostics.

·       Experience in developing and implementing quality and regulatory strategies.

·       In-depth knowledge of applicable legal requirements, including ISO 13485, IVDR, FDA.

·       Experience with ISO 15189/RiLiBÄK is desirable.

·       Strong problem-solving and decision-making skills.

·       Excellent communication, high social competence, and pronounced teamwork.

·       Successfully completed studies in quality management, regulatory affairs, or a technical/natural science discipline.


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