Head of Regulatory Affairs (Medical Devices, Hybrid)

Job summary

This role involves overseeing regulatory affairs for diagnostics products throughout their entire lifecycle, ensuring compliance with global regulations and standards. The position requires strategic oversight and collaboration with various stakeholders to maintain product safety and compliance in a dynamic regulatory environment.

Qualifications

• Leadership experience in a global organization with multiple stakeholders.
• Proven track record in regulatory affairs within the medical device sector.
• Deep understanding of ISO 13485, MDR, and FDA regulations.
• Strong analytical skills and structured documentation approach.
• Excellent communication skills in English, both written and verbal.

Responsibilities

• Manage end-to-end regulatory responsibilities for diagnostics products.
• Review and approve technical documentation prior to market release.
• Evaluate regulatory impacts of design changes and communicate requirements.
• Ensure compliance with MDR and FDA regulations.
• Oversee the product registration process for timely governmental approvals.
• Lead the clinical evaluation process during development and post-market activities.
• Develop and maintain regulatory intelligence and ensure implementation across functions.
• Manage a team of regulatory specialists and managers across various sites.

Skills

• Ability to assess regulatory risks and translate requirements into business implications.
• Experience with product lifecycle management and design change control processes.

Education

• Relevant degree in a scientific or regulatory field is preferred.

Tools

• Familiarity with regulatory compliance tools and documentation systems.