Compliance Engineer

Roles and Responsibilities :

• Ensure compliance with IEC, GSP, CE marking regulations for medical devices.
• Conduct risk assessments and develop mitigation strategies to minimize potential risks.
• Collaborate with cross-functional teams to design and implement compliant product designs.
• Develop and maintain documentation related to regulatory affairs.

Job Requirements :

• 5-12 years of experience in Compliance Engineer role within the Medical Devices industry.
• Strong understanding of IEC, GSP, CE marking regulations for medical devices.
• Experience with risk assessment methodologies and mitigation strategies development.
• Proficiency in creating technical documentation related to regulatory affairs.