Carsten Raunsgaard Email & Phone Number

Hørning, Dk

Overall responsible for ensuring regulatory compliance for all products sold worldwide.Furthermore responsible for ensuring use of proper software tools and having and following efficient R&D processes.Finally responsible for validation and testing during product development.

Denmark

Overall responsibility for ensuring that our products sold worldwide comply with all applicable regulations for where they are sold. This is done by implementing tools and processes.

I give product regulatory advice - further information can be found on my website: www.complianceadvise.com

Developed and implemented a company-wide ISO 19600 Product Regulatory Management System.Defined, had built (in India) and continuously enhanced a global repository (database) for product regulatory compliance verdicts.Introduced processes and tools for company-wide collection of substances information (REACH/RoHS/Conflict Minerals/Prop65) from all suppliers and led an operational team, for this task, in Slovakia.Based on a systematic collection of information, I have developed - from scratch - a web site containing regulatory news, home-created facts sheets and links to regulations and standards.I have conducted mentor training and trained people in compliance knowledge and given regulatory guidance to management and engineering during reviews and approvals, as well as in cases of non-compliances and customer complains.I have been working with people around the world and led people from Denmark, Sweden, Norway, USA and Slovakia reporting to me directly and led indirect reports from Japan, China, India, USA, Canada, UK, France, Italy, Germany and The Netherlands. This has given me a huge experience in leading on distance and using collaboration tools like e.g. Skype for video conferencing, sharing of presentations and calls.

Defined and had built a repository for storage of product regulatory compliance verdicts.Performed systematic collection of regulatory information and "translated" this to facts sheetsIntroduced subscription to standards and links to regulatory information.Introduced a web site for European regulations, with links and facts sheets, making it more simple for engineers to get a regulatory overview.Gave guidance to engineering and product management in regards to regulatory requirements for products as well as for environmental requirements to installation places - energy efficiency etc.Worked with product standards and coordinate company’s involvement in different standardisation groups, influencing international and domestic subcommittees that affect product and compliance standards.

Monitored for changes to regulations and standards and informed the business about these changes.Ensured that new regulatory requirements were introduced and implemented for products sold to/in Europe.Coordinate company’s involvement in different trade associations and standardisation workgroups. Informed and guided the business to understand regulatory requirements applicable for products sold in Europe.

Introduced substances regulations (REACH and RoHS) for the business and ensured compliance to these new environmental requirements.Monitored for changes to environmental regulations and standards and informed the business about these changes.Ensured that new regulatory requirements were introduced and implemented for products sold to/in Europe.Participated in different trade associations and standardisation workgroups, trying to influence regulations to the benefit of the company.Informed and guided the business to understand environmental regulatory requirements applicable for products sold in Europe.

Improvement of processes often require the right tools, from simple calculation tools to complex databases. I have used my technical knowledge to have a repository created, which have been linked together with other tools and web sites. I have systematically collected information about technical software and subscriptions used around the organization and where possible standardized and optimized the use of this.Part of the systematization of tools, I led an European project having the purpose to standardize/modularize refrigeration design. Creation of refrigeration modules in CAD systems and creation of calculation tools were part of my responsibility, together with my small team of engineers.

Developed and implemented an ISO 9001 Quality Management System. Including procedures and work instructions and a document control tool/database.Trained people in doing the right thing first time and how to follow defined processes.Led a small team responsible for internal IT support (hardware and CAD support). Set up procedures and tools for competence development for a team of 60 people. Gave training in the tool and processes and ensured that all had the right qualifications to perform their daily tasks.

Introduced and implemented an ISO 9001 based Quality Management System. Created and supported creation of procedures and work instructions.Performed Quality audits as a lead auditor and participated in environmental audits.Introduced handheld devises for registration of quality records (task performed).

Described and implemented a Quality Management System.Build (MS Access) and introduced a database for components (Approved vendor/manufacturer list)

Developed a training concept based on the "Learning Company" theoryConducted training in quality system principles.

Developed a "personal development concept" and trained people using this concept.

Participated in product development, ensuring "good quality", fulfilment of procedures and made risk assessments.Performed environmental testing of products to naval and aerospace requirements.

Electronic Engineering

Diploma In Specialized Business Studies, Organisation (Merkonom)