Head of Regulatory Affairs

Company

Our client is a small Medical Device manufacturer based in Tuttlingen. They are looking to strengthen their RA & QA department to keep all new and existing medical device products compliant with the new MDR as well as bringing new innovative products to market. The role will cover products in all lifecycle stages, from early design to well-established products.

The role will also be the acting PRRC in Europe for the wider Orthopaedic Group, coordinating their RA Strategy for access onto the European Markets.

Responsibilities

• Person Responsible for Regulatory Compliance (PRRC) in Europe for the wider Orthopaedic Group.
• Leading the Regulatory & Quality strategy and coordinating all related processes onsite, including management of a small team onsite.
• Responsibility for the continuous improvement of the Quality Management System (QMS).
• Ensuring all quality policies and objectives are translated into viable operating procedures, including any updates to the QMS.
• Primary point of contact for certification bodies, authorities and customers in all matters relating to quality and regulatory affairs.
• Coordinating external audits and leading internal audits for all companies in Europe.
• Ensuring complaint management and customer support on all quality and regulatory issues.

Requirements

• Higher Education in a relevant Scientific or Engineering field
• Extensive knowledge and experience working within ISO 13845 and regulatory affairs in Europe (MDD/MDR)
• At least 5 years of experience as a quality and regulatory manager in the medical sector, preferably leading a team.
• Experience with injection moulding processes is advantageous
• Excellent knowledge of the EU MDD and MDR.
• Full working proficiency in both German and English
• Developed communication & leadership skills.
• A self-starter capable of pragmatic planning to lead a dynamic environment.