Senior Regulatory Affairs Specialist

Job summary

The role involves managing regulatory activities related to registration documentation and product applications for medical devices, with a primary focus on FDA 510(K) and UK/EU MDR compliance. The position requires collaboration with a global regulatory team and interaction with various stakeholders.

Qualifications

• Experience in regulatory affairs, particularly with FDA and EU regulations.
• Strong planning and prioritization skills to meet deadlines.
• Excellent communication skills for effective collaboration with internal and external stakeholders.

Responsibilities

• Prepare and maintain registration documentation and product applications for regulatory submissions.
• Review and update technical files for the IVF devices product portfolio.
• Support the MDR filing process for class I and IIa devices.
• Maintain regulatory quality processes within the quality management system.

Skills

• Proficient in regulatory documentation and compliance processes.
• Ability to thrive in a dynamic work environment.

Education

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

Tools

• Familiarity with regulatory management software and quality management systems.