14 September Regulatory Networking Event

Kea Dent, Director, KD&A

In 2003 I established KD&A offering regulatory solutions to medical device manufacturers, legal representatives, and distributors in different markets around the world. As a regulatory and quality management system specialist for medical devices and IVD’s, my expertise lies in obtaining TGA and global regulatory product certifications. ISO 13485 quality system management creation, implementation, certification, maintenance and regulator audits. With over 30 years of experience in the medical device industry, I have direct experience in developing, manufacturing, marketing, selling and supporting innovative medical devices. I became involved in the medical device industry through establishing a successful manufacturing exporting company. The company exported 95% of the highly specialised medical devices to 44 countries. My personal success is displayed through my 2002 selection as the winner of the South Australian Telstra Business Woman of the Year in the private sector category. A few of my achievements are listed below: •Obtained many global regulatory certifications, these include CE marking (European Union), Food and Drug Administration 510(k) clearances (USA), Health Canada (Canada). TGA certifications (Australia), European Medicines Agency (EMA) and Medicines and Healthcare Products (MHRA, United Kingdom) approvals. •Created, implemented and maintained numerous quality management systems certified to ISO 13485.

Heyam Kalla, Associate Director, Team Lead Medical Devices / IVD, Pharmalex

Heyam Kalla is an experienced medical devices regulatory consultant with several years industry experience and specializes in high-risk devices and clinical evaluation reports. Heyam has held RA and QA roles in a multinational implant manufacturer and her current position as Associate Director, Team Lead Medical Devices / IVD, Australia at PharmaLex. She is experienced in regulatory pathway, planning and strategy for ANZ and global markets, as well as the preparation of regulatory filings, management of regulatory reviews and post market compliance management for a variety of devices, including high risk products. Heyam was awarded a Bachelor of Science with a double major in pharmacology and medical microbiology and immunology with first class honours in pathology from UNSW.

Kellie Shaw, Senior Regulatory Affairs Associate, Olympus Australia

Kellie Shaw is the Senior Regulatory Affairs Associate at Olympus Australia. With over twenty years in the medical device industry and a foundation in marketing and product management, she brings a unique perspective to regulatory affairs. Her decision to specialize in the regulation of medical devices and biologics is driven by her strong commitment to improving patient outcomes. Growing up with a brother who had a chronic illness gave her valuable insights into the importance of safe and effective treatment options for patients. Her commitment became more pronounced when her youngest daughter was diagnosed with type 1 diabetes, and it is these personal connections that fuel her passion for working in regulatory affairs. Kellie finds great satisfaction in knowing that her efforts behind the scenes make a difference in people’s lives every day.

Robert Young, Senior Regulatory Affairs Associate, LifeHealthcare

I have a more interesting path to where I am sitting than most people. My degree is as an agricultural scientist and my career in devices regulatory started with import/export and certifying cargo, vessel and border security requirements. This led to regulatory for lab supplies including some hospital lab medical devices to LMT Surgical looking after extremity orthopaedic, spine and neuro implants. I am now the Senior Regulatory Affairs Associate at Life Healthcare, who are part of the EBOS Group, As part of the EBOS Medtech division, our regulatory affairs team are currently managing the requirements for all 6 companies in the division. As the senior associate in a small team I have pre and post-market responsibilities across multiple portfolios as well as working on major projects, guidance and training of team members and working throughout the business on regulatory matters