Regulatory Compliance Specialist

About Us

Haldor Topsoe A/S is a leading global provider of technology and solutions for the energy transition. Our company strives towards having a safe work environment and continuously optimizes our safety procedures.

About the Position

We are looking for a highly skilled and detail-oriented Regulatory Compliance Specialist to join our EPCM team. The ideal candidate will have extensive knowledge of regulatory compliance, including CE marking and U.S. industry legislation.

The successful candidate will lead the CE marking process for new and existing products, ensuring compliance with EU directives and regulations. Additionally, they will ensure adherence to U.S. industry legislation, including FDA regulations, OSHA standards, and other relevant federal and state laws.

Main Responsibilities:

• Lead the CE marking process for new and existing products, ensuring compliance with EU directives and regulations.
• Ensure compliance with U.S. industry legislation, including FDA regulations, OSHA standards, and other relevant federal and state laws.
• Conduct comprehensive risk assessments and develop mitigation strategies to address potential compliance issues.
• Manage internal and external audits, ensuring adherence to ISO standards and other regulatory requirements.

Requirements:

• Regulatory compliance (EU and U.S.)
• CE marking
• Risk assessment according to ISO 12100
• ISO and IEC standards
• National legislation
• Quality management systems (QMS)
• Cross-functional team collaboration
• Strong interpersonal and communication skills