Regulatory Compliance Expert
CurrentAs a Regulatory Compliance Expert I provide guidance and expertise to manufacturers, importers and distributors within and outside the European Union. Main area of expertise is CE-marking and includes regulatory compliance for product groups such as: - Machinery and Installations (Machinery Directive 2006/42/EC and ATEX Directive 2014/34/EU);- Low Voltage Equipment (Low Voltage Directive 2014/35/EU);- EMC compatibility (EMC Directive 2014/30/EU);- Radio Equipment (Radio Equipment Directive 2014/53/EU);- Construction Products (Construction Products Regulation 305/2011);- Medical Devices (Medical Devices Directive 93/42/EEC and Medical Devices Regulation 2017/745);- Personal Protective Equipment (Personal Protective Equipment Regulation 2016/425);- Pressurized Equipment (Pressure Equipment Directive 2014/68/EU);- Toys (Toys Safety Directive 2009/48/EC).and various other CE-marking Directives.Further areas of expertise include European environmental regulatory acts (RoHS, WEEE), product liability, legal representation in dispute cases between economic operators and market surveillance authorities, intellectual property matters, global certifications (i.e. UL, CSA, EAC and CCC) and global market acces investigations.
