CE-Marking and Compliance Lead - Frederikssund and/or Hoersholm

About us
Topsoe is a leading global provider of technology and solutions for the energy transition. We combat climate change by helping our customers and partners achieve their decarbonization and emission reduction goals. Based on decades of scientific research and innovation, we offer world leading solutions for transforming renewable resources into fuels and chemicals for a sustainable world, and for efficient and low-carbon fuel production and clean air.We were founded in 1940 and are headquartered in Denmark, with over 2,800 employees serving customers all around the globe. To learn more, visit www.topsoe.com.

At Topsoe we strive towards having a safe work environment. We are aware of the risks in our work and continuously optimize our safety procedures.

Who we’re looking for
An highly skilled and detail-oriented CE and Compliance Specialist with over 8 years of experience in the global process industry. Extroverted and passionate about regulatory compliance, skilled in ensuring that production facilities meet all regulatory requirements and standards, including CE marking and U.S. industry legislation. Proven history of successfully navigating complex regulatory landscapes and implementing robust compliance programs to support business objectives.

Your responsibilities include:

• Lead the CE marking process for new and existing products, ensuring compliance with EU directives and regulations
• Ensured compliance with U.S. industry legislation, including FDA regulations, OSHA standards, and other relevant federal and state laws
• Conducted comprehensive risk assessments and developed mitigation strategies to address potential compliance issues
• Managed internal and external audits, ensuring adherence to ISO standards and other regulatory requirements
• Developed and maintained technical documentation, including Declarations of Conformity, Technical Files, and user manuals
• Collaborated with cross-functional teams to integrate compliance requirements into product development and manufacturing processes
• Provided training and support to staff on regulatory compliance and quality management systems
• Oversaw the implementation and maintenance of the company's compliance program, ensuring alignment with global regulatory standards, including U.S. industry legislation
• Conducted regular compliance audits and inspections, identifying areas for improvement and implementing corrective actions
• Cooperation with regulatory bodies and industry associations to stay up to date on changes in regulations and standards
• Developed and delivered training programs to enhance staff understanding of compliance requirements and best practices
• Successfully managed multiple compliance projects, resulting in improved regulatory adherence and reduced risk of non-compliance.

What you’ll bring
Key Skills:

• Regulatory Compliance (EU and U.S.)
• CE Marking
• The new Machine Regulation, Machinery Directive, ATEX, PED, EMC
• Risk Assessment according to ISO 12100
• ISO and IEC Standards
• National legislation
• Quality Management Systems (QMS) “can be selected”
• Internal and External Audits
• Technical Documentation
• Cross-functional Team Collaboration
• Continuous Improvement
• Training and Development
• Strong Interpersonal and Communication Skills.

Professional Experience:

• Industry Focus: Extensive experience in the process industry, with a strong emphasis on ensuring compliance with CE marking
• International Expertise: Acquired in-depth knowledge of American legislation and standards through professional engagements in the USA
• Safety Proficiency: Proficient in performance levels (PLr) and functional safety, adept at implementing effective safety measures
• ATEX Compliance: Specialist in ATEX directives, providing expert advice on explosion protection in hazardous environments
• National Legislation: Ensured adherence to national safety regulations, delivering tailored compliance solutions
• Client Collaboration: Enhanced safety for workers and processes, ensuring full compliance with relevant legislation and regulatory requirements.
  

Why join us
We can offer a great team environment, a brand-new office set up in Hoersholm, and a on-site office directly located at our catalyst production in Frederikssund.

Topsoe offers a great project portfolio with a wide range of investment projects to develop various leading decarbonization technologies that will play a kex role in the global fuel transition.

The EPCM team is a young and growing department where you will have the opportunity to be part of shaping the team, the project management operating model and support the project managers and engineers to deliver state of the art technology with full focus on safety and compliance.

We can offer you a flexible work set up to allow for a good balance between work and family and interesting activities for employees throughout the year.

How you can apply
Please contact Nicole Draheim, phone +45 2647 3933 email [email protected] if you want to know more about the position.

If you would like to be part of a team of skilled and professional colleagues in an informal organization, please submit your application and resume in Danish/English and enclose a copy of your references through our website www.topsoe.com.

To ensure a secure and trustworthy work environment, our recruitment process may include background checks and criminal record requests.