Head of Non-Active Medical Devices - Leading Notified Body
We are representing a leading Notified Body seeking an experienced Head of Non-Active Medical Devices to join their team. This is a pivotal leadership role within a globally recognized organization, providing regulatory expertise, strategic direction, and operational oversight for non-active medical device certification services.
Key Responsibilities:
- Lead and manage the Non-Active Medical Devices team, ensuring compliance with MDR (EU 2017/745) and other relevant regulations.
- Oversee technical file reviews, conformity assessments, and audits for a diverse portfolio of non-active medical devices.
- Act as a subject matter expert, providing regulatory guidance to internal teams and clients.
- Develop and maintain relationships with key stakeholders, including manufacturers, regulators, and industry bodies.
- Ensure the continuous development and training of the team to uphold the highest standards of technical competence.
- Contribute to the strategic growth of the division, driving efficiency and innovation in certification processes.
Key Requirements:
- Extensive experience in medical device certification, regulatory affairs, or quality assurance, ideally within a Notified Body or a regulatory consultancy.
- Strong knowledge of EU MDR (2017/745) and related international standards for non-active medical devices.
- Proven leadership skills with experience managing teams in a regulatory or compliance-driven environment.
- Excellent stakeholder management and communication skills.
- Ability to navigate complex regulatory landscapes and provide clear, pragmatic solutions.
