Laura Friedl-Hirst

Interim Senior Regulatory Affairs Executive

Laura is a very experienced member of our regulatory team with global Medical Device regulation experience for a wide range of products. With her excellent project management and knowledge on the implementation of the new regulations, she supports the clients through both major projects and their day to day regulatory concerns.

Value to clients

Laura is an expert in all regulatory aspects for medical devices and has worked throughout the product lifecycle management including concept/feasibility through to post market surveillance.

  • Experience with Class I (sterile), IIa and IIb medical devices within regulatory affairs for the European Union, Middle East and Asia
  • Knowledgeable in In vitro Diagnostics (general, List B, List A), cosmetics and general products.

Experience

After completing a BSc Degree in Medical Biology at the University of Huddersfield, Laura went straight into working within the regulatory affairs field. She has worked with small, medium and large sized medical device/IVD companies which include wound dressings, Molecular Diagnostics Oncology and infectious diseases, substance based devices, airway management and orthotic insoles.

Other things about Laura

  • She enjoys the problem solving aspect of regulatory affairs and ensuring the smooth transition of product to market
  • Laura has significant experience in risk management and technical file compilation
  • She is experienced with Quality Management Systems.
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